MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Device Alarm System (1012); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

Event Description

Called by patient's rn to troubleshoot bipap alarm reading "program crc test failure." unable to clear alarm saying it's a high priority alarm.Bipap continued to run uninterrupted even with this alarm going off.Patient was getting adequate ventilation and oxygenation.Switched out bipap so this one could be fixed.No harm done to patient.Manufacturer response for ventilator, v60 non-invasive (per site reporter).Our bmet spoke with the vendor, following information was provided: service notes (customer visible) philips technical support recommends that i redownload the software and if the problem reoccurs, to replace the cpu.They did not recommend that we replace the cpu for this one occurrence.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 12597901
• MDR Text Key: 275420459
• Report Number: 12597901
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA