BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 2140021 · Received June 25, 2011

    Report

    Report Number
    2031642-2011-00202
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 14, 2011
    Report Date
    June 1, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORT WAS RECEIVED FROM RISK MANAGEMENT AT (B)(6), THAT REPORTED THE FOLLOWING EVENT DESCRIPTION: PATIENT NOTED TO BE IN SLIGHT RESPIRATORY DISTRESS, BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MACHINE FOUND TO BE IN THE OFF POSITION. MACHINE WAS EXAMINED AND NOTED TO BE CONNECTED TO POWER SOURCE BUT FOUND IN THE OFF POSITION. DEVICE WOULD NOT TURN TO THE ON POSITION. THE CUSTOMER RETURNED THE UNIT TO THE (B)(6) AND THERE WAS NO REPORT MADE TO THE MANUFACTURER OF THE EVENT UNTIL RECEIPT OF THE MEDWATCH FORM. UPON RECEIPT OF THE MEDWATCH FORM, THE MANUFACTURER CONTACTED THE RENTAL AGENCY REGARDING THE REPORTED PROBLEM AND THE RENTAL AGENCY REPORTED THEY HAD NO KNOWLEDGE OF THE EVENT. THE MANUFACTURER'S SERVICE TECHNICIAN REQUESTED ACCESS TO THE DEVICE FOR EVALUATION. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT, HOWEVER, REPORTED WHEN THE DEVICE WAS POWERED ON IN VENTILATION MODE IT DISPLAYED A 35 VOLT HIGH PRIORITY ALARM. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED OCCURRENCES OF A 35 VOLT FAILURE, HOWEVER, OCCURRENCES WERE AFTER THE REPORTED DATE OF EVENT. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT PCB BOARD TO ADDRESS THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS. ANALYSIS OF THE POWER MANAGEMENT BOARD REVEALED A COMPONENT SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other