BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2961074 · Received January 16, 2013

    Report

    Report Number
    1218950-2013-00194
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    January 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE WOULD NOT CHARGE THE BATTERY. NO PATIENT INVOLVEMENT WAS REPORTED. THE CUSTOMER PERFORMED THE EVALUATION. THE CUSTOMER LOCALIZED THE ISSUE TO A FAILED AC POWER SUPPLY AND REQUESTED A PART ID. A FOLLOW UP CALL WAS MADE TO THE CUSTOMER. THE CUSTOMER'S BIOMED STATED HE REPLACED THE AC POWER SUPPLY WHICH RESOLVED THE ISSUE. THE DEVICE WAS PUT BACK INTO SERVICE. BASED ON THE CUSTOMERS REPORT, WE ARE CONSIDERING THIS A MALFUNCTION OF THE AC POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT CHARGE THE BATTERY. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24968 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1