BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 727276 · Received July 9, 2005

    Report

    Report Number
    1220908-2005-01480
    Event Type
    Malfunction
    Date Received
    July 9, 2005
    Date of Event
    June 14, 2005
    Report Date
    June 15, 2005
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORP HAS RECEIVED THE PRODUCT.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO TREAT A FEMALE PT WHO WAS SYMPTOMATIC BRADYCARDIA THE DEVICE FAILED TO PROVIDE APCING THERAPY TO THE PT. THE REQUIRED IMMEDIATE PACING, THE DEVICE WAS ATTACHED TO THE PT VIA. A FOUR LEAD ECG CABLE AND PACING PADS. THE INITIAL SETTING SET AT 0 MA AND 70 BPM AS DEFAULT. HOWEVER, RATHER THAN THE EXPECTED 70 PACER SPIKES THERE WAS ONLY ONE THAT PRECEDED EVERY QRS COMPLEX. THE MA WAS SLOWLY ADJUSTED TO 140 MA WITH NO CHANGE IN THE DISPLAYED RATE AND THE ACTUAL PACING GOING TO THE PT WAS ERRATIC AND IRREGULAR. THE RATE ON THE SCREEN NEVER CHANGED FROM THE INITIAL 40-50.THE BPM WAS INCREASED FROM 70 UP TO 100 AND THAT ONLY CREATED A CHANGE UP TO 66-70 ON THE SCREEN. ANOTHER MEDIC ARRIVED AND ATTACHED THEIR DEVICE TO THE LEAD CABLES AND PACING PADS THAT WERE ON THE PT. THE DEVICE WAS SET TO 92 MA AND TO 70 BPM AND IMMEDIATELY OBTAINED A PERFUSING PT HEART RATE AT 70 BEATS PER MINUTE ALONG WITH A CORRESPONDING MONITOR READING. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other