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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 02/11/2020.

Event Description

The customer reported that the power management printed circuit board assembly (pm pcba) was replaced during a service event for a separate problem, and after replacement of this part, the ventilator was turning itself on intermittently.There was no patient involvement.

Manufacturer Narrative

G4: 31mar2020.B4: 13apr2020.The customer reported that the unit cannot be turned off unless the battery and alternate current (ac) power are disconnected.The customer confirmed that replacing the power management printed circuit board assembly (pm pcba) did not resolve the problem.Technical support advised the customer to replace the display or user interface (ui) pcba.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: 29may2020.B4: 29may2020.The customer reported that replacing the user interface printed circuit board assembly resolved the problem.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: 9696614
• MDR Text Key: 183926701
• Report Number: 2031642-2020-00469
• 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
• Report Date: 02/11/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 01/14/2020; 01/14/2020
• Supplement Dates FDA Received: 04/13/2020; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1