PHILIPS HeartStart FR3 with ECG and Rigid Case
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION · Model 860364
FR3 ECG, US English, Rigid System Bundle
Intended use: A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.
Key tips
- ·A no-signal/flatline alarm gets checked on the patient first, not the monitor - rule out a real clinical event before troubleshooting.
- ·Recalibrate NIBP against a reference manometer, not just a self-test pass.
- ·Reused patient cables (SpO2, ECG leads) are a common source of intermittent-fault complaints - swap the cable before the module.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
ECG lead-off / artifact
MediumSymptoms: Flat or noisy ECG, frequent lead-off alarms.
Root cause: Worn electrodes, loose leads, or dry gel.
SpO2 probe / sensor failure
MediumSymptoms: No pleth, SpO2 drops to --- or false low.
Root cause: LED/photodiode aging or cable damage.
Internal battery depletion
HighSymptoms: Short backup time, battery alarm on transport.
Root cause: Aged backup battery.
Display / touch panel fault
LowSymptoms: Dim, flickering, or unresponsive screen.
Root cause: Backlight or digitizer failure.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
SpO2 sensor (adult/ped/neo)
Class Frequent wear itemRel. cost $$R&R Easy
NIBP cuff & hose
Consumable per patient.
Class Periodic replacementRel. cost $R&R Easy
Rechargeable backup battery
Class Periodic replacementRel. cost $$R&R Fairly easy
Display / touch assembly
Class Periodic replacementRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| SpO2 sensor (adult/ped/neo) | Frequent wear item | $$ | Easy |
| NIBP cuff & hose Consumable per patient. | Periodic replacement | $ | Easy |
| Rechargeable backup battery | Periodic replacement | $$ | Fairly easy |
| Display / touch assembly | Periodic replacement | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Routine cable and lead-wire inspection for fraying/wear
- ·Battery conditioning cycle
- ·NIBP calibration check against a reference manometer
- ·ECG / SpO2 accuracy verification against a patient simulator
- ·Annual electrical safety test
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: ECG lead-off / artifact
- Confirm the presentation - typically flat or noisy ECG, frequent lead-off alarms - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: worn electrodes, loose leads, or dry gel.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the eCG patient cable & lead set per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: SpO2 probe / sensor failure
- Confirm the presentation - typically no pleth, SpO2 drops to --- or false low - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: lED/photodiode aging or cable damage.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the spO2 sensor (adult/ped/neo) per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- Height
- 13.4 in
- Length
- 7.7 in
- Weight
- 13.2 lbs base unit with 1 battery/pads and pads cable
- Defibrillator Type
- External, Automated (AED)
- Width
- 12.4 in
- MRI safety
- MR Unsafe
- Sterile
- No
- Single use
- No
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Non-rechargeable public automated external defibrillator
- FDA product classification
- Automated External Defibrillators (Non-Wearable)
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- ICU / CCU
- Emergency Department
- OR / PACU
- General med-surg floors
- Step-down units
- Telemetry units
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
- RECALL
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
- RECALL
Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.
- RECALL
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
- RECALL
The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.
- RECALL
Multiple software and hardware issues with device that can affect its function.
- RECALL
When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
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