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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 21jul2020.

Event Description

The customer reported that the unit alarmed with a check vent machine pressure sensor autozero error failure while on a test lung. The customer contacted product support and was advised to turn and off the unit to see if the problem will returned. Per the service manual, product support recommend replacing the solenoid valve and provided the part number. The customer reported that the unit was not in use on a patient. The biomedical engineer said that he could not duplicate the reported problem. He said that he turned on and of f the unit all day and the reported error did not returned. The unit is now back in service.

• 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: 10305677
• MDR Text Key: 200598049
• Report Number: 2031642-2020-02450
• 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: 06/29/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/21/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: V60
• Device Catalogue Number: 1053617
• 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: 06/29/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse