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

Model Number V60

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The international manufacturer's service technician reported a capacitor on the central processing unit pcba had shorted. There was no patient involvement.

• 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 Contact: phyllis mccarthy ; 2271 cosmos court; carlsbad, CA 92011
• MDR Report Key: 5060499
• MDR Text Key: 25810280
• Report Number: 2031642-2015-01737
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/08/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Device MODEL Number: V60
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse