BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPS SYSTEM

    MDR report key: 12421 · Received March 31, 1994

    Report

    Report Number
    MW1001374
    Event Type
    Injury
    Date Received
    March 31, 1994
    Date of Event
    January 15, 1994
    Report Date
    January 31, 1994
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RETURNED HOME FROM 30 DAY VISIT TO HOSP AND THE INFUSION BATTERY PACK WOULD NOT HOLD A CHARGE. RPTR REPLACED THE PACK WITH A NEW ONE, AND TOOK THE DAMAGED PACK OUT OF SERVICE. RPTR WAS ADVISED BY THE MFR THAT THE PACK COULD NOT BE REPAIRED. RPTR FOUND THAT THE PACK HAD NOT BEEN KEPT PLUGGED IN TO AN OUTLET DURING THE PT'S HOSP STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPS SYSTEM EXTERNAL POWER SOURCE FOR INFUSION PUMP FRN PHARMACIA DELTEC, INC. 21-2339

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention