BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHYSIO CONTROL

    MDR report key: 316463 · Received February 12, 2001

    Report

    Report Number
    MW4002909
    Event Type
    Other
    Date Received
    February 12, 2001
    Date of Event
    January 29, 2001
    Report Date
    February 7, 2001
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    WHILE WORKING A FULL ARREST, FACILITY CHARGED THE QUICK-COMBO PADS WHICH WERE APPLIED ANTERIOR/POSTERIOR AND DEFIBRILLATED THE PT FOR THE 5TH TIME. UPON DISCHARGING THE MONITOR, THERE WAS AN ARCH FROM THE ANTERIOR PAD. THE ARCH APPEARED TO HAVE COME FROM THE AREA NEAR THE CABLE WHERE IT ATTACHED TO THE PAD. FACILITY IMMEDIATELY SWITCHED TO A NEW SET OF PADS WHILE ADMINISTERING DRUG THERAPY AND CPR. THE INCIDENT DID NOT CAUSE ANY INJURY TO THE PT OR THE PARAMEDICS ON THE SCENE. IT ALSO DID NOT CHANGE THE OUTCOME OF THE CALL. PT CARE WAS NEVER COMPROMISED. REPORTER IS ONLY FORWARDING THIS TO FACILITY AS A MATTER OF DOCUMENTATION OF THE INCIDENT. UNFORTUNATELY, THE PADS AND PACKAGING WERE NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5437 PHYSIO CONTROL LIFE PACK 10 QUICK-COMBO PADS LDD PHYSIO-CONTROL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other