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

Model Number V60

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09sep2020.

Event Description

It was reported to philips that the check button was missing from the navigation ring.There was no patient involvement or user harm reported.The customer evaluated the device with assistance from a philips remote service engineer (rse).The rse advised the customer that they can just order and replace the button, or they can replace the entire front bezel.Part information for both the navigation ring button pack of five (5) was provided and the part information for the bezel.

Manufacturer Narrative

G4: 29oct2020 b4: (b)(6) 2020 the customer replaced the navigation ring button to resolve the issue of the missing check button.The device remains at the customer site and was placed back into service.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: 10512217
• MDR Text Key: 207172481
• Report Number: 2031642-2020-03201
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: 08/19/2020

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1