BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL PADDLES ADAPTER CABLE

    MDR report key: 1823287 · Received August 28, 2010

    Report

    Report Number
    1218950-2010-01427
    Event Type
    Malfunction
    Date Received
    August 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A PADS ADAPTER CABLE FAILURE THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE CUSTOMER WAS GIVEN INSTRUCTIONS FOR ORDERING A REPLACEMENT. THE CUSTOMER DID NOT SUBMIT THE DEVICE TO PHILIPS FOR EVALUATION. BASED ON THE CUSTOMER'S REPORT, HOWEVER, WE WILL CONSIDER THIS TO BE A MALFUNCTION OF THE PADS ADAPTER CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PADS ADAPTER CABLE FAILURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL PADDLES ADAPTER CABLE MKJ PHILIPS HEALTHCARE M4740A

    Patients

    Seq Age Sex Outcome Treatment
    1