BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2945911 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00075
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 14, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE DOES NOT SWITCH ON. NO PATIENT INVOLVEMENT WAS REPORTED. THE DEVICE WAS EVALUATED BY A PHILIPS FSE, BUT THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE, SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DOES NOT SWITCH ON. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7773 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1