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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Event Description

Patient on high frequency jet ventilation nurse called renal therapist (rt) to say jet all of a sudden stopped working giving jet valve malfunction and ventilator fault.Rt changed patient box and turned jet off and on but not change would not work.Changed out jet#3.Biomed is testing jet per oem specs.

• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr; salt lake UT 84115
• MDR Report Key: 9457661
• MDR Text Key: 170455526
• Report Number: 9457661
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Type of Device Usage: N
• Patient Sequence Number: 1