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

Model Number V60

Device Problems No Display/Image (1183); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07oct2020.

Event Description

It was reported to philips that the display was not coming on and the unit would only power on with the ac power and not battery.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer (biomed) with assistance from a philips remote service engineer (rse).The rse advised the biomed to try swapping ui assemblies with a known good one to narrow the issue down.

Manufacturer Narrative

G4:23nov2020.B4:24nov2020.The remote service engineer contacted the customer on 29-sep-2020 who stated that replacement of the user interface pcba resolved the issue.Based on information provided and/or service performed, the customers alleged malfunction was confirmed.The device was not being used for treatment when the reported event occurred.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.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: 10645679
• MDR Text Key: 212316821
• Report Number: 2031642-2020-03620
• 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
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1