LifePulse 312Recalls & reported problems
Bunnell, Incorporated · LifePulse High Frequency Ventilator - Patient Box Model 312 · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616120000013), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
4 other recalls cover devices cleared under the same FDA submission (P850064); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Displays Incorrect Message1
- Device Inoperable1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2017Device Inoperable; Device Displays Incorrect Message
NICU PATIENT WAS ON THE JET VENTILATOR WHEN THE VENTILATOR DISPLAYED VENTILATOR FAULT AND SHUT DOWN. THE VENTILATOR WAS TURNED OFF AND THEN BACK ON WITH NOTHING WORKING STILL. PATIENT WAS MANUALLY VENTILATED WHILE A NEW VENT WAS BROUGHT OVER. IT WAS A LENGTHY PROCESS, SO THE PATIENT WAS MANUALLY VENTILATED FOR ABOUT 20 MINUTES. THE PATIENT WAS PLACED ON THE NEW JET VENTILATOR AND WAS STABLE. BUNNELL WAS CONTACTED AND WE ARE TROUBLESHOOTING THE PROBLEM WITH THE VENTILATOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7040463 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P850064. One submission often covers many models, so check the product and lot details in each record.
- Z-0514-2013 · Nov 19, 2012 · TerminatedPatient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s):
- Z-0902-2011 · Oct 25, 2010 · TerminatedOne Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
- Z-0901-2011 · Oct 25, 2010 · TerminatedOne Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
- Z-0893-06 · Apr 4, 2005 · TerminatedLife Pulse High Frequency Ventilator (HFV)
Other Ventilator, High Frequency devices
- 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 768901Carefusion Corporation · Ventilator, High Frequency4 deaths587 reports
- 3100B HFOV 770155Carefusion Corporation · Ventilator, High Frequency1 death61 reports
- 3100A HFOV 768901-RNTCarefusion Corporation · Ventilator, High Frequency55 reports
- LifePort 2.5 mmBunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- 3100A HFOV 768901Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY30 reports
- 3100A HFOV 768901-RFBCarefusion Corporation · Ventilator, High Frequency18 reports
- 3100A HFOV 29028-011Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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