BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8675562 · Received June 6, 2019

    Report

    Report Number
    2031642-2019-03537
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Report Date
    May 23, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC¿D BY MFR : 27MAY2019, DATE OF REPORT : 25JUL2019. THE DATA ACQUISITION (DAQ) BOARD WAS RETURNED FOR FAILURE INVESTIGATION FOR FURTHER INVESTIGATION. NO ANOMALIES WERE FOUND WHEN CONDUCTING VISUAL INSPECTION. THE DAQ BOARD THEN WAS INSTALLED TO THE FAILURE INVESTIGATION UNIT TO REPLICATE THE REPORTED ISSUE AND CONDUCT FUNCTIONAL TESTS. THE FI GROUP WAS UNABLE TO REPLICATE REPORTED FAILURE. NO FAULT WAS FOUND. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 06JUNE2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE VENTILATOR FAILED THE PRESSURE ACCURACY TEST. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466932 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1