BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 3859921 · Received June 10, 2014

    Report

    Report Number
    3004593495-2014-00018
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 22, 2014
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    PMA / PMN Number
    K132924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE DISPLAY FRAME HAD FLUID CONTAMINATION/CORROSION, THE UPPER CASE SHOWED FLUID INGRESSION AROUND THE ENCODER AREA, ENCODER NUTS WERE NOT TORQUED APPROPRIATELY, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AS A PREVENTIVE MEASURE, THERE WAS RESIDUE AROUND THE PCB. IT WAS ALSO NOTED THAT DUE TO THE TYPE OF TESTER USED, THE FACILITY WOULD NOT GET ACCURATE READINGS WHEN USING THIS TESTER TO TEST THIS DEVICE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED TO INVESTIGATE THE TORQUE SETTING ON THE ENCODER NUTS. CONCLUSION: THE DHR DID NOT CONTAIN DATA POTENTIALLY OR DIRECTLY ASSOCIATED WITH THE TORQUE SETTING ON THE ENCODER NUTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DID NOT PASS THE SAFETY TEST IN THE BIOMEDICAL ENGINEERING DEPARTMENT OF THE HOSPITAL. THE EPG WAS TESTED BY THE PACER MODE OF THE FLUKE BIOMEDICAL IMPULSE 7000DP. THE ENGINEER REPORTED THAT THERE WERE NORMAL VALUES IN THE VENTRICULAR MODE, HOWEVER, WHEN TESTING THE ATRIAL MODE, THE PARAMETERS FOR RATE, PULSE WIDTH, AMPLITUDE AND ENERGY WERE SHOWN ON THE TESTING MACHINE AS UNSATISFACTORY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICING. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341588 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1