BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5224017 · Received November 15, 2015

    Report

    Report Number
    8043817-2015-00008
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    September 22, 2015
    Report Date
    November 13, 2015
    Manufacturer
    MICROTEK DOMICANA, S.A
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AT THE MANUFACTURING SITE IN THE (B)(4). BASED ON THE DMR REVIEWED, PRODUCT NUMBER ORS-100, LOT NUMBER D152311 HAD (B)(4) PIECES THAT WERE MANUFACTURED ON 08/18/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE INVESTIGATION REVEALED THAT THIS PROBLEM WAS NOT DUE TO AN ASSEMBLY, MATERIAL, OR PROCESS ISSUE. NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    AN END USER FOUND THAT A WARMER DRAPE HAD A HOLE IN IT. THE DRAPE WAS REMOVED AND NOT USED ON THE PATIENT. A NEW DRAPE FROM THE SAME LOT WAS OPENED; THERE WAS NO HOLE IN THE SECOND DRAPE. THE REPORT WAS FOR PART NUMBER ORS-100, LOT NUMBER 1037708. BECAUSE THE DRAPE WAS NOT USE ON THE PATIENT, IT APPEARS THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754059 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMICANA, S.A ORS-100 D132311

    Patients

    Seq Age Sex Outcome Treatment
    1