MAUDE Adverse Event Report: BUNNELL, INCORPORATED; VENTILATOR, HIGH FREQUENCY

Device Problems Device Alarm System (1012); Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2020

Event Type  malfunction  

Event Description

During generator testing, jet vent failure alarm-vent unable to restart.Vent plugged into red outlet with back-up battery on and functioning.Pt was ventilated manually during event, spo2 100% for duration of vent circuit being changed.Pt returned to jet post circuit change.

• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr; s salt lake UT 84115
• MDR Report Key: 10612561
• MDR Text Key: 209398872
• Report Number: 10612561
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1