BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2233083 · Received July 26, 2011

    Report

    Report Number
    1218950-2011-02140
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT WAS NOT RECOGNIZING THE HANDS FREE CABLE WHEN PERFORMING THE OPERATIONAL CHECK. THEY NOTED A PADS CABLE FAILURE MESSAGE, AND IN THEY INDICATED THAT THERE WAS A THERAPY CABLE FAILURE MESSAGE IN THE STATUS LOGS. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZE TO THE POWER PCA. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS NOT RECOGNIZING THE HANDS FREE CABLE WHEN PERFORMING THE OPERATIONAL CHECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1