BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUAM

    MDR report key: 61240 · Received January 6, 1997

    Report

    Report Number
    61240
    Event Type
    Injury
    Date Received
    January 6, 1997
    Date of Event
    August 24, 1996
    Report Date
    August 26, 1996
    Manufacturer
    *
    Product Code
    HFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MONITOR DELIVERED TO PT AS REPLACEMENT. MONITOR ALARMED "NEEDS CHARGING" INSPITE OF BEING CHARGED WITH A/C ADAPTER FOR GREATER THAN 3 DAYS. MONITOR TESTED 8/96. END/OUTCOME. PT DELIVERED PRE-TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUAM UTERINE MONITOR HFM * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization