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U.S. Department of Health and Human Services

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

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Failure to Zero (1683)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2018. Date of report: 17sep2019. The data acquisition (da) pcba and oxygen solenoid valve was disassembled from the gds and not returned with the gds assembly. Visual inspection of the gas delivery system (gds) assembly revealed no evidence of damage or contamination. The u1 and eeprom u2 that contains the sensor calibration data was replaced on the air flow sensor pcba. The defective u1 on the air flow sensor pcba created the air and o2 flow accuracy test to fail. Mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018. As this has been reassessed, it will appear to be a late mdr.

 
Event Description

The customer reported that the air flow accuracy test failed at zero slpm. The customer reported there was no patient involvement.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, 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 Key9075541
MDR Text Key192144305
Report Number2031642-2019-09515
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 07/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberV60
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/09/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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