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

Model Number V60

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23apr2020.

Event Description

The customer reported that the power management (pm) board was replaced, the unit smoked at turned on.The customer contacted product support and requested for service repair.The customer reported that the unit was not in use on a patient.

Manufacturer Narrative

Date received by mfr: 20may2020.Date of report: 27may2020.The field service engineer (fse) evaluated the unit and found that power management (pm) board is missing from the unit.The motor controller (mc) board has damaged component (capacitor).The (fse) replaced the pm pcba, mc pcba (printed circuit board assembly) to address the reported issue.The mc board wingnuts, screws, three bottom feet, and power cord retainer are missing are all user induced problem.These are all replaced during servicing of this unit.

Manufacturer Narrative

Date received by mfr: 11jun2020.Date of this report: 12jun2020.The unit was repaired by the bench repair engineer not by philips field service engineer.

Manufacturer Narrative

Date rec¿d by mfr: 01may2020.Date of report: 13may2020.Serial#: (b)(4).Bench repair engineer provided the correct serial number.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

G4: (b)(6) 2020.B4: (b)(6) 2020.Failure analysis on the returned motor controller (mc) board shows that the customer complaint was verified.Root cause was failure of c187.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: 9991888
• MDR Text Key: 188973793
• Report Number: 2031642-2020-01507
• Device Sequence Number: 1
• Product Code: MNT
• 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,Followup,Followup,Followup
• Report Date: 04/06/2020

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: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/06/2020; 04/06/2020; 04/06/2020; 04/06/2020
• Supplement Dates FDA Received: 05/13/2020; 05/27/2020; 06/12/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1