BEUDAMED
    FDA Adverse Event Summary report: N

    LIFEPAK DEFIBRILLATOR/MONITOR

    MDR report key: 18260 · Received September 19, 1994

    Report

    Report Number
    MW4000570
    Date Received
    September 19, 1994
    Report Date
    September 19, 1994
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR/MONITOR WAS TAKEN TO BIOMEDICAL EQUIPMENT REPAIR SHOP BECAUSE THE RECORDER WOULD NOT RECORD LEAD I TRACINGS. BMET CONNECTED PT CABLE TO AN EKG SIMULATOR AND COULD NOT GET A TRACING ON MONITOR OR A PAPER RECORDING ON LEAD I. BMET THEN REALIZED THAT THE DEVICE USES A THREE LEAD PT CABLE, BUT THIS ONE HAD ARRIVED WITH A FIVE LEAD PT CABLE. THE CORRECT PT CABLE (PART# 9-10418-02) WAS USED ON THIS DEVICE AND AGAIN TESTED WITH THE EKG SIMULATOR. UNIT WAS FULLY FUNCTIONAL AND RETURNED TO SERVICE. IT WAS OBSERVED THAT A FIVE LEAD PT CA (CO'S PART #9-10417-00) WILL PLUG INTO DEVICE THE SAME AS A THREE LEAD CABLE. IT WAS ALSO DISCOVERED THAT THREE LEAD PT CABLE (PART# 09-10418-1) WILL ALSO PLUG INTO THE DEVICE, BUT WILL INVERT LEAD I DISPLAY (THIS CABLE IS FOR USE ON ANOTHER MODEL). SINCE OTHER MFR'S CABLES WILL ALSO PLUG INTO THE CABLE PORT, BIOMEDICAL EQUIPMENT MAINTENANCE WILL PRINT AND ATTACH A LABEL TO EACH CABLE, AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL CORP. 10

    Patients

    Seq Age Sex Outcome Treatment
    1 *