
Smiths Medical · Model PneuPac babyPAC 100
Unique variable oxygen concentration gas mixing system Inspiratory pressure control Separate controls for inspiratory and expiratory time Four operating modes PEEP/CPAP control Adjustable pneumatic pressure relief with audible alarm Integrated pressure monitoring/alarm system Low gas supply indicators for 02 and air Complete pneumatic operation Lightweight and durable MR Conditional: 3 Tesla actively shielded magnet max gradient of 430 G/cm, 0.82 W/kg at 125.5 Mhz.
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.
Symptoms: Self-test fault, circuit-leak or compliance-check failure, will not be released for use.
Root cause: Patient-circuit / expiratory-valve leak, a flow-sensor fault, an O2-cell fault, or an internal pneumatic fault.
Symptoms: Delivered tidal volume or flow does not match the setting, or fails the annual verification.
Root cause: Flow-sensor drift / contamination, an inspiratory / expiratory valve fault, or a blender / proportioning-valve fault.
Symptoms: Low-supply alarm, FiO2 not matching the setting, O2-cell reads wrong.
Root cause: Wall / cylinder supply issue, an inlet filter / regulator fault, the blender, or an aged O2 cell.
Symptoms: PEEP drifts, auto-PEEP, high-pressure alarms, poor exhalation.
Root cause: Worn or wet expiratory valve / diaphragm, or a blocked exhalation path.
Symptoms: Short internal-battery run time, will not charge, transfers to battery unexpectedly.
Root cause: Aged internal battery or a power-supply fault.
Symptoms: Noisy operation, cannot meet flow demand, turbine / compressor alarm.
Root cause: Worn turbine / compressor.
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.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Flow sensor(s) | Frequent wear item | $$ | Fairly easy |
| Expiratory valve / diaphragm | Frequent wear item | $$ | Fairly easy |
| O2 cell / sensor | Frequent wear item | $$ | Easy |
| Internal battery | Periodic replacement | $$ | Fairly easy |
| Inlet filters / water traps | Frequent wear item | $ | Easy |
| Turbine / compressor (turbine units) | Major service part | $$$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
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.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
Uncertainty in the seal integrity of the sterile packaging.
The incorrect device is contained in the package.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
The labeling was missing information on sterilization and prohibition of reuse.
Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due
Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.
Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.
Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
From BioLab, for work done with this kind of equipment.
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