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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Battery Problem (2885)

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

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020. Date of this report: 06 oct 2020.

Event Description

It was reported that the ventilator had a battery fault during testing. There was no patient involvement. The service engineer (se) inspected the device. The se found a battery failed alarm and re-connect the battery, but the problem still existed. The se replaced the battery to address the reported issue. The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.

• 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; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10639190
• MDR Text Key: 211957224
• Report Number: 2031642-2020-03595
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/15/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/06/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: V60
• Device Catalogue Number: 1076716
• Was Device Available For Evaluation?: Yes

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/07/2020
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse