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

Model Number V60

Device Problem Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 08mar2021.

Event Description

The customer reported a ventilator's nav-ring was unable to adjust settings when the numbers were jumping during device setup.The device was evaluated by the customer and a philips field service engineer (fse) confirmed the reported problem.The device was not in clinical use at the time the issue was discovered.The issue was found during pre-use set-up.There was no patient or user harm reported.There was no delay to patient therapy because the facility had other ventilators in the department.The fse replaced the front bezel.The device was tested and reported to be fully functional.No other anomalies were reported.

Manufacturer Narrative

A front bezel was returned for analysis, and it was identified that previous investigations have shown liquid ingress is due to the variability of the assembly process causing the reported navigation ring failure.

• 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: 11440965
• MDR Text Key: 240601275
• Report Number: 2031642-2021-00879
• 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: 01/13/2022

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: 12/20/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2014
• 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