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

Model Number V60

Device Problem Key or Button Unresponsive/not Working (4063)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 09feb2021.

Event Description

It was reported to philips that the navigation ring was not working when trying to adjust the settings during preventative maintenance.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The customer requested that a philips field service engineer (fse) be dispatched to the customer site to provide additional assistance.

Manufacturer Narrative

G4:02mar2021.B4:06mar2021.H11:g5:k102985.H10: the philips field service engineer replaced the front bezel assembly to resolve the issue.The device remains at the customer site.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

The front bezel was returned for analysis.Failure investigation is not required.The root cause of navigation-ring failures was determined to be due to liquid ingress.Previous investigations have identified that liquid ingress, due to the variability of the assembly process, causes navigation ring failures.

• 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): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11304606
• MDR Text Key: 240620681
• Report Number: 2031642-2021-00488
• 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,Followup
• Report Date: 02/11/2022

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 Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/12/2021; 02/08/2022
• Supplement Dates FDA Received: 03/07/2021; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2013
• 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