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

Event date: (b)(6) 2018.Date of report: 10jan2019.A follow-up report will be submitted once the investigation is completed.

Event Description

The customer reported multiple power management (pm) printed circuit board (pcb) voltage failures.The device was not in use at the time of the reported event; therefore, there was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec'd by mfr: 22feb2019.The manufacturer¿s technical services (ts) confirmed the reported issue.Check vent codes 3.3 v supply failed -1117, mc pcba adc failed-111d, 35 v supply failed-111b, ovp circuit failed -1127, 5 v supply failed-1118 were identified.The customer was advised to replace the blower and to swap this (power management) pm pcba into another unit to gauge if it is bad out of stock.If the pm pcba is good when placed into another unit to replace the (motor controller) mc with a known good mc pcba.The customer replaced the defective motor controller board to address the reported problem.The unit successfully passed the required performance verification test.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: 8235734
• MDR Text Key: 132917730
• Report Number: 2031642-2019-00229
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1