BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHED INTERNAL PADDLES - 7.5 CM

    MDR report key: 2222424 · Received July 14, 2011

    Report

    Report Number
    1218950-2011-02010
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    LDD
    PMA / PMN Number
    K021453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A SET OF INTERNAL PADDLES HAD FAILED WHILE IN USE ON A PT. THERE WAS NO REPORT OF NEGATIVE IMPACT TO THE PT. ANOTHER SET OF INTERNAL PADDLES WERE OBTAINED. THE CUSTOMER ORDERED A NEW SET OF PADDLES WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SET OF INTERNAL PADDLES HAD FAILED WHILE IN USE ON A PT. THERE WAS NO REPORT OF NEGATIVE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCHED INTERNAL PADDLES - 7.5 CM LDD PHILIPS HEALTHCARE - ANDOVER M4741A

    Patients

    Seq Age Sex Outcome Treatment
    1