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

Model Number V60

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of this report: 12/17/2018.(b)(4).Philip's international service technician replaced the power management (pm) printed circuit board assembly (pcba) and the motor controller (mc) pcba to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.

Event Description

During periodic maintenance, the manufacturer¿s international service technician reported that occurrences of multiple codes indicating a 3.3 volt supply failure were identified in the device logs.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 01/14/2019 pma/510k 04/27/2019 failure analysis on the returned power management (pm) board and motor controller (mc) board shows that the customer complaint of ¿ 3.3v supply failed was confirmed.The problem was traced to u10 on the mc board.No problem found on the power management (pm) board.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: 8171450
• MDR Text Key: 130773236
• Report Number: 2031642-2018-02886
• 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
• Report Date: 10/15/2018

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 04/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1