BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5473997 · Received March 2, 2016

    Report

    Report Number
    8043817-2016-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Report Date
    November 23, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K023282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 1043774 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOT D152681. THE DHR WAS REVIEWED FOR THIS LOT AND IT WAS SEEN THAT THIS LOT HAD 1920PCS AND IT WAS MANUFACTURED ON 09/25/2015. 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 REPORTED THAT THE WARMER DRAPE 44 X 66 HAS RIPPED EASILY AND HAS GOTTEN BURNT. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    AN END USER REPORTED THAT THE WARMER DRAPE 44X66 RIPPED EASILY AND HAS BEEN BURNT. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131364 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-330N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1