BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5452167 · Received February 22, 2016

    Report

    Report Number
    8043817-2016-00020
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    October 20, 2015
    Report Date
    January 7, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. 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

    NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. 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 1039702 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152541, D152571, D152531, D152331, D151681, D151331. THE DHR WAS REVIEWED FOR D151331RC. THIS LOT HAD (B)(4) PIECES AND WAS REPACKAGED. NO DEFECTS WERE REPORTED IN PROCESS,PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151681ARC. THIS LOT HAD (B)(4) PIECES AND WAS REPACKAGED. NO DEFECTS WERE REPORTED IN PROCESS PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D151331. THIS LOT HAD (B)(4) PCS. NO DEFECTS WERE REPORTED IN PROCESS,PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D152571A. THIS LOT HAD (B)(4) PCS. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D152531. THIS LOT HAD (B)(4) PCS. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR D152541. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/08/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AFTER FINISHING THE CASE, THE ROOM WAS BEING CLEANED AND THE SCRUB TECH PICKED UP THE DRAPE TO THROW IT AWAY, THEY NOTICED IT WAS LEAKING. THERE WAS A HOLE IN THE DRAPE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    AFTER FINISHING THE CASE, THE ROOM WAS BEING CLEANED AND THE SCRUB TECH PICKED UP THE DRAPE TO THROW IT AWAY, THEY NOTICED IT WAS LEAKING. THERE WAS A HOLE IN THE DRAPE. THERE WERE NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109516 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other