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
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.
Symptoms: Low exhaled tidal volume, high leak alarm, inability to maintain PEEP.
Root cause: Diaphragm/valve degraded by secretions and cleaning cycles.
Symptoms: Unexpected shutdown, persistent low-battery alarm.
Root cause: Aged internal battery or failed PSU.
Symptoms: Leak alarm, low circuit pressure, volume loss.
Root cause: Disconnected or punctured patient circuit / humidifier.
Symptoms: FiO2 out of range, oxygen alarm.
Root cause: Failed solenoid or proportional valve in blender.
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.
Most-replaced wearable part; stock spares.
Consumable, replace per PM schedule.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Exhalation valve assembly Most-replaced wearable part; stock spares. | Frequent wear item | $$ | Fairly easy |
| Flow / differential pressure sensor | Periodic replacement | $$$ | Moderate |
| Bacterial / HEPA filter Consumable, replace per PM schedule. | Consumable | $ | Easy |
| Compressor / turbine module | Periodic replacement | $$$ | Difficult |
Relative cost: $ lowest · $$$$ 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 structured starting point derived from the failure modes above. 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.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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