BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ-5000 EQUATOR CONVECTIVE WARMER

    MDR report key: 3833413 · Received May 19, 2014

    Report

    Report Number
    2183502-2014-00318
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    DWJ
    PMA / PMN Number
    K011907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. THE USER FACILITY RETURNED THREE CONVECTIVE WARMING UNITS FOR EVALUATION AS THEY WERE UNSURE WHICH UNIT WAS INVOLVED IN THE REPORTED EVENT. EACH UNIT WAS CONNECTED TO AN APPROPRIATE POWER SUPPLY AND GIVEN FUNCTIONAL, CALIBRATION, AND ELECTRICAL SAFETY TESTING. ALL THREE UNITS PASSED ALL TESTING WITHIN SPECIFICATIONS. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS DEVICE-CAUSED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE DEVICE WAS POWERED ON AND CONNECTED TO A CONVECTIVE WARMING BLANKET TO BE PLACED IN USE WITH A PATIENT. DURING PLACEMENT OF THE WARMING BLANKET AND WHILE HOLDING THE CONVECTIVE WARMING DEVICE, THE USER RECEIVED A SHOCK. TWO ECG TESTS WERE PERFORMED THAT DAY. THE USER REPORTED DISCOMFORT IN THEIR CHEST,NECK, AND HEAD THE FOLLOWING DAY. THE USER WAS ADMITTED TO CORONARY CARE UNIT FOR OBSERVATION WHERE AN ADDITIONAL ECG TEST WAS PERFORMED. USER DID NOT REPORT ANY ISSUES LATER IN THE DAY. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY; NO INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295372 EQ-5000 EQUATOR CONVECTIVE WARMER DWJ -- CONVECTIVE WARMER DWJ SMITHS MEDICAL ASD, INC. EQ-5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization