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

Model Number V60

Device Problems Blower (738); Insufficient Cooling (1130)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 20aug2020.

Event Description

It was reported to philips by the customer (biomed) that the v60 ventilator displayed an over temperature error. The device was not being used on a patient at the time of the event. There was no adverse event to the patient or user as a result of this event. The device was evaluated by the customer with assistance from a philips remote service engineer (rse). The rse advised the customer to verify the v60 cooling fan is running, and to verify the air inlet filter is clean. The rse also asked the biomed to check the significant event log for over temperature errors, however the biomed is unable to locate any temperature errors in the log. A philips field service engineer (fse) was dispatched to the customer site. The reported issue was confirmed and traced to a faulty blower. The blower assembly was replaced to resolve the reported issue.

• 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; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10434853
• MDR Text Key: 204198862
• Report Number: 2031642-2020-02880
• 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
• Report Date: 07/29/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/20/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: V60
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse