MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Electrical /Electronic Property Problem (1198); Inappropriate or Unexpected Reset (2959)

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

Event Type  Injury  

Manufacturer Narrative

Event date: (b)(6) 2018.(b)(4).A follow-up report will be submitted once the investigation is completed.

Event Description

The customer reported that the "check vent: 35 volt supply failed" alarm, the "check vent: auxiliary alarm supply failed" alarm and the "check vent: backup alarm failed" alarm occurred, the blower became inoperative and the device rebooted.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 21feb2019.Date rec¿d by mfr: 08jan2019.The power management board was returned to philips for failure analysis.Testing revealed that the solder crack was open and not making contact with the trace, causing the reported error codes.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

Mfr received date: 26 oct 2018.Further investigation of this record yielded findings of patient harm in association to the event noted.Subsequent to the sequence of events resulting in unanticipated cessation of positive pressure therapy and device shutdown, the patient was removed from the disabled ventilator and placed on supplemental oxygen therapy via low flow nasal cannula set to 5 liters per min.Low flow oxygen therapy continued as an on-site medical engineer replaced the malfunctioning unit with a functioning device.Patient mild desaturation was noted during event with a decrease from approximately 90-91% spo2 to approximately 80% spo2 with low flow oxygen therapy.No significant harm or serious adverse event was noted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 7970307
• MDR Text Key: 123959402
• Report Number: 2031642-2018-02203
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN
• Patient Age: 92 YR
• Patient Weight: 46