BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5435457 · Received February 12, 2016

    Report

    Report Number
    8043817-2016-00013
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    February 8, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE RECEIVED ON 12/21/1205 AND REVIEWED ON 12/31/2015. SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. THEN VISUALLY CHECKED FOR HOLES OR LEAKS. NO HOLES, LEAKS OR TEARS WERE NOTED IN THE DRAPE. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. 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

    ONE SAMPLE RECEIVED ON 12/21/1205 AND REVIEWED ON 12/31/2015. SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. THEN VISUALLY CHECKED FOR HOLES OR LEAKS. NO HOLES, LEAKS OR TEARS WERE NOTED IN THE DRAPE. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. 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 1041439 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152511, D152521, D152521A, D152031, D152471, D152381, D152011, D152021, D151531. THE DHR WAS REVIEWED FOR LOT D152511. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/08/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152521. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/09/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152521A. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/09/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152381. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/26/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152471. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/04/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. LOT D152031. THIS DHR COULDN'T BE REVIEWED BECAUSE THIS LOT WAS NOT ASSIGNED.

    Description of Event or Problem · 1

    CUSTOMER HAD THREE DRAPES TEAR DURING SURGERY BUT ONLY HAVE ONE SAMPLE RETURNED TO (B)(4) FOR EVALUATION/REVIEW. PRODUCT NUMBER IS OM-ORS-300 AND LOT # 1041439. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER HAD THREE DRAPES TEAR DURING SURGERY BUT ONLY HAD ONE SAMPLE TO RETURN TO (B)(6) FOR EVALUATION/REVIEW. THERE WERE NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92208 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1