BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5434039 · Received February 12, 2016

    Report

    Report Number
    8043817-2016-00012
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    February 10, 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 RECEIVED ON 12/21/2015 AND REVIEWED ON 12/31/2015. SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. CUSTOMER CLAIMED HOLE WAS NOT FROM A BURN MARK. EXAMINED SAMPLE AND FOUND SMALL BURN HOLE. CUSTOMER CIRCLED HOLE WITH GREEN MARKER. 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 RECEIVED ON 12/21/2015 AND REVIEWED ON 12/31/2015. SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECK USED SAMPLE AND TOOK PHOTOS. CUSTOMER CLAIMED HOLE WAS NOT FROM A BURN MARK. EXAMINED SAMPLE AND FOUND SMALL BURN HOLE. CUSTOMER CIRCLED HOLE WITH GREEN MARKER. 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: LOT 1043776 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152591, D151901. THE DHR WAS REVIEWED FOR LOT D151901. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 7/10/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152591. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 09/16/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. BASED ON THE DHR REVIEW, IT DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE.

    Description of Event or Problem · 1

    NURSE DISCOVERED A HOLE IN THE DRAPE DURING A PROCEDURE. SAYS IT'S NOT BECAUSE OF MELTING. NO REPORT FOR PATIENT TREATMENT OR MEDICATION. REGULATORY BECAME AWARE OF THE INCIDENT ON (B)(6) 2016.

    Description of Event or Problem · 1

    NURSE DISCOVERED A HOLE IN THE DRAPE DURING A PROCEDURE. SAYS IT'S NOT BECAUSE OF MELTING. NO REPORT FOR PATIENT TREATMENT OR MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92634 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1