BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORS-320 SLUSH WARMER DISC DRAPE

    MDR report key: 7476239 · Received May 1, 2018

    Report

    Report Number
    8043817-2018-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 13, 2018
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    UDI-DI
    00748426112463
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NUMEROUS ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN THE SAMPLE BUT A RESPONSE WAS NOT RECEIVED. THE DHR WAS REVIEWED AND IT WAS CONFIRMED THAT LOT D172361 HAD (B)(4) CASES THAT WERE MANUFACTURED FROM 08/24/17 TO 08/26/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. BASED ON THE DEVICE HISTORY RECORD THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. SINCE NO SAMPLE WAS PROVIDED THE NON CONFORMITY COULD NOT BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING CASE, CIRCULATOR NOTICED SALINE IN WARMER NOT CONTAINED IN STERILE DRAPE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319631 ORS-320 SLUSH WARMER DISC DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320 D172361 00748426112463

    Patients

    Seq Age Sex Outcome Treatment
    1