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

Model Number V60

Device Problem Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 15sep2020.

Event Description

The customer reported system down.There was no patient involvement.

Manufacturer Narrative

The device was sent to a 3rd party for pm and informed the customer that the nav-ring wasn't working.The 3rd party requested that a philips field service engineer (fse) be dispatched to their site to replace the front bezel.The fse confirmed nav-ring required replacement.The fse replaced the v60 front bezel to resolve the issue.The device passed testing and was returned to service.It was determined that liquid ingress, due to variability of the assembly process, was the root cause of the reported failure.Upon further review, the reported issue has been deemed not reportable as the device was outside of clinical use when it was discovered; and does not present a potential risk of patient harm or injury.This issue occurred during periodic maintenance (pm).Based on this information, this complaint no longer meets regulatory reporting criteria.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10537965
• MDR Text Key: 208557278
• Report Number: 2031642-2020-03278
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1