BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4883695 · Received July 1, 2015

    Report

    Report Number
    2031642-2015-01188
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2015. CONCLUSION / ROOT CAUSE: THE MOTOR CONTROLLER (MC) PCBA AND POWER MANAGEMENT (PM) PCBA WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THE UNIT ALARMED DUE TO AN OVER CIRCUIT PROTECTION (OVP) FAILURE INDICATING THE 12/3.3 OVP CIRCUIT DID NOT DETECT A 3.3 OVERVOLTAGE CONDITION WHILE THE CUSTOMER WAS PERFORMING A PERFORMANCE VERIFICATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THE UNIT ALARMED DUE TO AN OVER CIRCUIT PROTECTION (OVP) FAILURE INDICATING THE 12/3.3 OVP CIRCUIT DID NOT DETECT A 3.3 OVERVOLTAGE CONDITION WHILE THE CUSTOMER WAS PERFORMING A PERFORMANCE VERIFICATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426032 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1