BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-PACE

    MDR report key: 696051 · Received March 23, 2006

    Report

    Report Number
    MW1038339
    Event Type
    Malfunction
    Date Received
    March 23, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 23, 2006
    Manufacturer
    PACE MEDICAL INC.
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NURSE HAD NOTICED PT RATE WAS AT 60 BPM INSTEAD OF 90 BPM. THE NURSE HAD NOTICED THE DISPLAY WAS OFF ON THE PACEMAKER. SHE TURNED UNIT OFF AND THEN BACK ON AND THE UNIT DID NOT TURN BACK ON. SHE DID NOT RECALL IF THE LOW BATTERY ICON WAS FLASHING AT AN EARLIER TIME. SHE REPLACED THE PACEMAKER ON THE PT AND THE REPLACEMENT IS OPERATIONAL. THE NURSE HAD REPLACED THE BATTERIES IN THE UNIT THAT SHUT DOWN AND POWERED ON, THE UNIT POWERED UP PROPERLY. THE ORIGINAL BATTERIES HAD BEEN THROWN AWAY. PULLED UNIT TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-PACE EXTERNAL PACEMAKER DRO PACE MEDICAL INC. 4570 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *