BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5470332 · Received March 1, 2016

    Report

    Report Number
    8043817-2016-00023
    Event Type
    Malfunction
    Date Received
    March 1, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE NON CONFORMITY DOESN'T APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS ISSUE. SINCE A SAMPLE WAS NOT REVIEWED, THE NON CONFORMITY COULD NOT BE CONFIRMED. 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

    BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE NON CONFORMITY DOESN'T APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIALS ISSUE. SINCE A SAMPLE WAS NOT REVIEWED, THE NON CONFORMITY COULD NOT BE CONFIRMED. 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 1040518 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D151941, D151671, D151661, D151731, D151821. THE DHR WAS REVIEWED FOR LOT D151941 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151671 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 9/30/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151661 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/27/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151731 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/24/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D151821 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND WAS REPACKAGED ON 10/29/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. BASED ON THE DHR REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AN END USER REPORT OF LEAKS ON WARMER DRAPE ORS-300, 44 X 4, NOTICED WHEN DRAPES WERE BEING REMOVED FROM THE SOLUTION WARMERS. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKS IN DRAPE. NO PATIENT INJURY OR TREATMENT WERE REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127266 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1