Unify Quadra™
ST. JUDE MEDICAL, INC. · Model CD3249-40
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV.
Intended use: An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
Key tips
- ·Never skip the daily/shift ready-check - a defibrillator found dead during a code is a real, repeated root-cause finding.
- ·Pads and batteries have real expiration dates - check them on every PM, not just at annual service.
- ·Verify energy-delivery accuracy with a real defibrillator analyzer, not just a self-test pass.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Will not power on or unexpected shutdown
HighSymptoms: The defibrillation & emergency is dead, reboots, or shuts down mid-use.
Root cause: Mains lead / fuse, an aged battery, or a power-supply board fault.
Battery will not hold charge
MediumSymptoms: Short run time on battery; low-battery alarm soon after a full charge.
Root cause: Aged rechargeable battery pack or a charger fault.
Display / control-panel fault
MediumSymptoms: Blank, dim or distorted display; unresponsive keys or touchscreen.
Root cause: Display, backlight, or control-board fault.
Fails self-test or calibration
MediumSymptoms: Power-on self-test or the scheduled performance check fails or is out of tolerance.
Root cause: Sensor drift or an internal board fault; recalibration or repair needed.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Rechargeable battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Power supply / mains board
Class Major service partRel. cost $$$R&R Difficult
Display / control-panel assembly
Class Major service partRel. cost $$$R&R Moderate
Cooling fan
Class Major service partRel. cost $R&R Moderate
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Power supply / mains board | Major service part | $$$ | Difficult |
| Display / control-panel assembly | Major service part | $$$ | Moderate |
| Cooling fan | Major service part | $ | Moderate |
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.
- ·Daily/shift visual and self-test check (AAMI EQ56 daily-ready standard)
- ·Battery and pad expiration-date tracking
- ·Energy-delivery accuracy test against a defibrillator analyzer
- ·Paddle/cable continuity check
- ·Annual full PM
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Will not power on
- Confirm the outlet, mains lead and fuse.
- Try on battery, then on mains only, to isolate the supply.
- Look for a power indicator or POST code.
- Replace the fuse / battery / power supply as isolated.
- Run the self-test after any repair.
Symptom: Fails self-test or calibration
- Note the exact failure message / code.
- Power-cycle and repeat the self-test.
- Verify against a reference / simulator where one applies.
- Recalibrate per the service manual.
- Refer the affected board for service if it will not hold calibration.
Technical Specs
- Handling Environment Temperature
- -20°C to 60°C
- Storage Environment Temperature
- 50°F to 113°F
- Total Volume
- 40 Milliliter
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Cardiac resynchronization therapy implantable defibrillator
- FDA product classification
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Manufacturer support
- +1(855)478-5833 · customerservice@sjm.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Crash carts (every unit)
- Emergency Department
- ICU
- OR
- Code-blue response areas
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
- RECALL
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
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