BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE WITH SKIRT

    MDR report key: 7474265 · Received April 30, 2018

    Report

    Report Number
    8043817-2018-00013
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Report Date
    April 13, 2018
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    UDI-DI
    00748426106929
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RECEIVED FOR EVALUATION. THE DRAPE WAS DECONTAMINATED THEN PLACED OVER A WARMER. WATER WAS POURED INTO THE WARMER AND LEFT OVERNIGHT. THERE WAS WATER IN THE BASIN UNDER THE DRAPE. A SMALL BURN MARK WITH A VERY SMALL, UNNOTICEABLE HOLE WAS FOUND. THE DHR WAS REVIEWED AND IT WAS CONFIRMED THAT LOT D172213 HAD (B)(4) CASES THAT WERE MANUFACTURED FROM 08/10/2017 TO 08/13/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    OPERATING ROOM (OR) TECHS SAID THERE WAS FLUID UNDER THE DRAPE FOLLOWING A SURGERY IT WAS USED ON. THEY SAID THAT THE FLUID LEVELS IN THE WARMER WERE KEPT AT APPROPRIATE LEVELS THROUGHOUT THE CASE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315396 WARMER DRAPE WITH SKIRT FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-188231 D172213 00748426106929

    Patients

    Seq Age Sex Outcome Treatment
    1