BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS V60

    MDR report key: 2932899 · Received January 22, 2013

    Report

    Report Number
    MW5028756
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    PHILLIPS HEALTHCARE OF NORTH AMERICA
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(4), MALE, IN THE ICU WITH DIAGNOSIS OF PNEUMONIA, ON BI-PAP FOR APPROX 7 DAYS, DEVELOPED DETERIORATION IN RESPIRATORY STATUS. THE BI-PAP DEVICE ALARMED, AND STAFF ATTEMPTED TO TROUBLE-SHOOT THE ALARM. AS STAFF WAS PREPARING FOR AN ELECTIVE INTUBATION OF THE PT, THE DEVICE ALARMED "TEMP INOPERABLE" AND SHUT DOWN COMPLETELY. THE BI-PAP DEVICE WAS CHANGED OUT, AND THE PT WAS SUCCESSFULLY INTUBATED ELECTIVELY. THE PHILLIPS CUSTOMER SERVICE REP CAME IN AND INSPECTED THE AFFECTED UNIT. A FINAL REPORT WAS OBTAINED (B)(6) 2013 AND STATED THE FOLLOWING: "CLAIMS MOTOR FAILED TO DELIVER BREATH. ENERGIZED UNIT, BLOWER DID NOT OPERATE. DUPLICATED COMPLAINT. REPLACED BLOWER. BLOWER OPERATED AND DELIVERED BREATHS. INSTALLED 2.10 SOFTWARE. PERFORMED PERFORMANCE VERIFICATION AND UNIT PASSED SUCCESSFULLY. NEXT ANNUAL PM DUE AT (B)(4) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31561 RESPIRONICS V60 V60 VENTILATOR MNT PHILLIPS HEALTHCARE OF NORTH AMERICA 850008 V60 100061053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention