BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5445438 · Received February 18, 2016

    Report

    Report Number
    8043817-2016-00016
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Report Date
    January 5, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. THEN VISUALLY CHECKED FOR HOLES OR LEAKS. NO HOLES, LEAKS OR TEARS WERE NOTED IN THE DRAPE. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

    Additional Manufacturer Narrative · 1

    SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. THEN VISUALLY CHECKED FOR HOLES OR LEAKS. NO HOLES, LEAKS, OR TEARS WERE NOTED IN THE DRAPE. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. FOLLOW UP #1: AN UNUSED DRAPE WAS RETURNED TO THE MANUFACTURER WITH THE USED DRAPE. THE UNUSED DRAPE DID NOT HAE ANY BURNS, HOLES, OR TEARS. LOT 1041696 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D151391, D151401, D152661, D152591 THE DHR WAS REVIEWED FOR LOT D151391 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 08/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151401 AND IT WAS SEEN THAT THIS LOT HAD 4680PCS AND IT WAS MANUFACTURED ON 05/21/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D152661 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 09/23/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D152591 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 09/16/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. AFTER REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THE NON CONFORMANCE DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE.

    Description of Event or Problem · 1

    AN END USER REPORTED THAT THE DRAPES OM-ORS-300 WERE LEAKING DURING SCOPE WARMING PROCEDURES.

    Description of Event or Problem · 1

    AN END USER REPORTED THAT THE DRAPES OM-ORS-300N WERE LEAKING DURING SCOPE WARMING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102905 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1