BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP EXTERNAL PACEMAKER

    MDR report key: 324622 · Received April 3, 2001

    Report

    Report Number
    324622
    Event Type
    Injury
    Date Received
    April 3, 2001
    Date of Event
    February 1, 2001
    Report Date
    April 2, 2001
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED VIA AMBULANCE TO THE ED WITH ACUTE ONSET ON ANTERIOR CHEST PAIN ASSOCIATED WITH SHORTNESS OF BREATH. APICAL PULSE 36-50 AND BP OF 88 SYSTOLIC. PT REC'D ATROPINE X3 WITH NO CHANGE IN CONDITION. UPON ARRIVAL IN ED PT PLACED ON OXYGEN AND AN EXTERNAL PACEMAKER WAS INITIATED WITH RATE OF 70. PT HAD IMMEDIATE RESPONSE WITH INCREASE OF BP AND O2 SATS. DURING THE NIGHT THE RN'S REPORTED TO THE ED MD THAT THE PACER WAS ON BUT THEY QUESTIONED A MALFUNCTION. ED MD TOLD THEM IT WAS OKAY, THE DAY SHIFT ALSO QUESTIONED A MALFUNCTION WHILE THE PACER WAS ON. MD ORDERED PACER OFF, UNLESS PARAMETERS WERE MET. PT DID NOT MEET PARAMETERS, SO PACER WAS NOT ON. PT WAS TRANSPORTED TO CT SCAN AND UPON ARRIVAL IN ICU PT HAD DETERIORATED AND THE PACER WAS OFF. AN EMERGENT TEMPORARY PACER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14611 HP EXTERNAL PACEMAKER EXTERNAL PACEMAKER DRO AGILENT TECHNOLOGIES M17722B *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention