BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5445936 · Received February 18, 2016

    Report

    Report Number
    8043817-2016-00017
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Report Date
    December 15, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: THE DHR WAS REVIEWED FOR LOT D152503 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 09/07/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D143091 AND IT WAS SEEN THAT THIS LOT HAD 4800 PCS AND IT WAS MANUFACTURED ON 11/05/2014. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY 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, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.

    Description of Event or Problem · 1

    ECOLAB-MICROTEK SALES REPRESENTATIVE REPORTED THAT THE DRAPE LEAKED INTO THE WARMING PAN. ECOLAB-MICROTEK REPRESENTATIVE STATED THEY DISCOVERED THE LEAK AFTER THE CASE. THE DRAPE WAS USED DURING THE PROCEDURE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT THE DRAPE LEAKED INTO THE WARMING PAN. REP STATED THEY DISCOVERED THE LEAK AFTER THE CASE. THE DRAPE WAS USED DURING THE PROCEDURE. NO PATIENT INJURY OR TREATMENT WERE REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102636 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100N D152501 D143091

    Patients

    Seq Age Sex Outcome Treatment
    1