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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  Malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 15sep2020.

Event Description

The customer reported that the unit have an "error" message during use on patient. Found during service. On/off overlay flickering green light emitting diode (led) when pressed and unit failed flow accuracy test for oxygen mix accuracy. The customer reported that the unit was in use on patient , but there was no patient harm reported. The field service engineer (fse) found during service, on/off overlay flickering green led when pressed. Flow accuracy did not pass specification for oxygen mix accuracy.

• 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: 10538425
• MDR Text Key: 208168983
• Report Number: 2031642-2020-03294
• 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: 08/26/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/15/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: V60
• 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: 08/26/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 06/04/2013
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse