MAUDE Adverse Event Report: BUNNELL, INC. WHISPER JET; VENTILATOR, HIGH FREQUENCY

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a copy of the medwatch report (b)(4) was received from the fda.Until that date, bunnell was unaware of this situation.Bunnell contacted the customer and initiated a formal bunnell customer complaint.Earlier this year, the patient was on a jet ventilator when it was noted that the device would not deliver the programmed setting.The infant was taken off the jet ventilator and provided positive pressure ventilation for 40 minutes.The jet ventilator was changed to another jet ventilator to finish the treatment.What was the intended procedure: high frequency mechanical ventilation.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

Manufacturer Narrative

(b)(6) (respiratory therapist) reported that the patient box was set-up on a patient but would not read the peep, the peep display was zero.He pulled the life pulse system (vent and pb) and placed the patient on (b)(6) 2014 a different life pulse ventilator which worked fine.The did troubleshooting on the vent (s/n (b)(4)) with a different pb and the vent worked fine.They ran the pb 4587 on a different vent and had the same result, no peep.The pb will be returned to bunnel for service after it is release by risk management.There was no patient injury associated with switching the life pulse systems.The patient box has been serviced at the recommended annual intervals, with the last service (b)(4) 2013.If the patient box is returned for evaluation, this medwatch report will be updated.

• Brand Name: WHISPER JET
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; salt lake city UT 84115
• Manufacturer Contact: brent thackeray ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 3808349
• MDR Text Key: 4524762
• Report Number: 1719232-2014-00002
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/01/2014,04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 2