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) 2019.Date of report: 12/19/2019.

Event Description

It was reported that the diagnostic code related to ventilator restart due to anomalies occurred during periodic maintenance.There was no patient involvement.The manufacturer¿s international service technician evaluated the ventilator and confirmed the reported problem.The service technician replaced the central processing unit printed circuit board assembly and the problem was resolved.

Manufacturer Narrative

G4: 17mar2020.B4: 19mar2020.The replaced central processing unit (cpu) printed circuit board assembly (pcba) was returned for failure analysis.The cpu pcba was tested and no failures were identified.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: 9500125
• MDR Text Key: 181195895
• Report Number: 2031642-2019-10928
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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: 01/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1