BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5470568 · Received March 1, 2016

    Report

    Report Number
    8043817-2016-00024
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    January 21, 2016
    Report Date
    February 3, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 1040007 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 REPACKAGED 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 09/30/2015. 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 FROM (B)(6) IS REPORTING OF LEAKS ON WARMER DRAPE ORS-300N, 44IN X 66IN, DISCOVERED AT THE END OF A PROCEDURE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER SAID THERE WAS A HOLE FOUND IN THE DRAPE AFTER A CASE AND REPORTED THAT THE DRAPE WASN'T EXTENDED AT THE FOLDS AND WAS FOLDED OVER IN THE UNIT. CUSTOMER CONFIRMED THAT SAMPLE WAS TOO CONTAMINATED TO SEND IN FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127283 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1