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

Model Number V60

Device Problems Blower (738); Filter (816); Defective Component (2292); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(4) 2020. Date of report: 12jul2020.

Event Description

The customer reported that the unit failed with blower temperature high error. The customer contacted product support and was advised that the unit could have dirty filters, a faulty blower, or motor controller board error. The caller determined that the air inlet filter may be occluded and was not aware that they needed to be replaced more than annually. Product support advised the customer that the air inlet filter is to be checked or replaced every 250 hours. The customer reported that the unit was in use on a patient, but there was no patient harm reported. The customer replaced the air inlet filter to address 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: 10262539
• MDR Text Key: 199294850
• Report Number: 2031642-2020-02323
• 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
• Report Date: 06/18/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/13/2020
• 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: 06/18/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse