BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1841588 · Received September 17, 2010

    Report

    Report Number
    1218950-2010-01647
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED, A THERAPY CABLE FAILURE DURING OP-CHECK OF THE DEVICE. THE DEFIBRILLATOR WAS RETURNED TO PHILIPS FOR EVAL. THE REPORTED SYMPTOM WAS REPRODUCED. REPLACEMENT OF THE THERAPY CABLE AND PORT RESOLVED THE SYMPTOM. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS MORE THAN ONE PART WAS REPLACED.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED, A THERAPY CABLE FAILURE DURING OP-CHECK OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1