MAUDE Adverse Event Report: BUNNELL LIFE PULSE; VENTILATOR, HIGH FREQUENCY

Model Number 203A

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Hypoxia (1918)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The jet ventilator stopped working.An error message on the jet ventilator lit up: "ventilator fault".The patient's spo2 dropped to 86%.The patient's endotracheal tube (ett) was removed from jet ventilator and nurse (rn) began manually ventilating (bagging) the patient; the patient's sp02 returned to 100%.New jet ventilator obtained and the ett was transferd to the new jet ventilator.
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manufacturer response for jet ventilator, high frequency jet ventilator (per site reporter)
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the jet ventilator was due for preventive maintenance in two weeks, under service contract.The ventilator was shipped back to manufacturer for service.Report received from manufacturer: "the whisper jet passed the self-test and operational verification".Under-went inspection, cleaning and calibration.Final validation after service: passed service operational verification and passed quality control inspection.Jet ventilator shipped back to our facility a month after inspection.

• Brand Name: LIFE PULSE
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 4544558
• MDR Text Key: 5510936
• Report Number: 4544558
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 203A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2014
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 DAY
• Patient Weight: 3