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

Model Number V60

Device Problems Use of Device Problem (1670); Defective Component (2292)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 15feb2021.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.

Event Description

The customer called into technical support (ts) reporting that the device¿s nav-ring is not working and unable to adjust the settings.Requesting onsite service for nav-ring replacement.The customer reported there was no patient involvement at the time the issue was discovered.

Manufacturer Narrative

G4:22mar2021.B4:02apr2021.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem of the nav-ring not working and unable to adjust the settings.The fse replaced the front bezel to return the device back to working condition.The device passed all tests successfully and was returned unit to 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.

Manufacturer Narrative

H11: it is unknown if the unit was in inpatient use at the time of the reported issue; however, no patient or user harm was reported.H10: the front bezel was returned back for failure investigation, 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: 11327969
• MDR Text Key: 233255989
• Report Number: 2031642-2021-00601
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 12/20/2021
• Supplement Dates FDA Received: 04/02/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• 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