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

Model Number V60

Device Problems Blower (738); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 26may2020.

Event Description

The customer reported a high blower temperature alarm. The ventilator was being used on a patient at the time of the reported event, however, there was no patient harm. The patient's information was not provided. The patient had to be moved to a different ventilator as a result of this event. There was no additional medical intervention being required. The field service engineer (fse) evaluated the ventilator and confirmed the occurrence of the reported alarm. The fse installed new air inlet filter, cleaned the cooling fan filter, and verified that the cooling fan motor was operating within specifications. The ventilator successfully passed functionality testing after repair was completed.

• 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: 10087992
• MDR Text Key: 192388194
• Report Number: 2031642-2020-01844
• 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

• Type of Report: Initial
• Report Date: 05/05/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/26/2020
• 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?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse