BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER

    MDR report key: 5811761 · Received July 21, 2016

    Report

    Report Number
    1216677-2016-00050
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    November 28, 2015
    Report Date
    June 24, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE COMPLAINT WILL BE RETURNED. COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION. NO SAMPLE RETURNED. REVIEW DHR. INSPECT RETURNED SAMPLES. INSPECT STOCK PRODUCT. ANALYSIS AND FINDINGS: PRISTECH INVESTIGATION. RESPONSE RECEIVED FROM SUPPLIER. SUPPLIER FOUND THAT REVIEW OF THE BATCH RECORDS INDICATED ALL SAMPLES MET REQUIREMENTS. POTENTIAL CAUSE FOR NOT ACHIEVING 102-105 F COULD BE PRODUCT WAS ACTIVATED AT A TEMPERATURE BELOW RECOMMENDATION AND THEREFORE THE MATTRESS FELT COOLER THAN NORMAL. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION: CONTINUE TO MONITOR. CORRECTIVE ACTION LEVEL 4: TRAIN PERSONNEL. NONE. REASON: NO CHANGES TO PROCESS OR PROCEDURES. WAS THE COMPLAINT CONFIRMED? YES. REVIEW AND CLOSURE: CAPA REQUIRED? RECOMMENDED CONTINUOUS IMPROVEMENT PROGRAM (CIP) COMPLAINT CLOSURE LETTER REQUIRED? NCMR ISSUED? OTHER REGULATORY ACTION NEEDED: PREVENTATIVE ACTION ACTIVITY: REVIEWED. TREND AND MONITOR TO CIP.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH MW5061596. (B)(4). "TRANSWARMER WOULD NOT ACTIVATE/WARM. HAD TO GRAB ANOTHER THAT DID ACTIVATE TO WARM MATTRESS FOR PREEMIE BABY. THIS IS THE 2ND TIME THIS HAS HAPPENED WITH THIS EXACT PRODUCT. STAFF DIDN'T KEEP FIRST TRANSWARMER FOR REPORTING INFO."

    Description of Event or Problem · 1

    REFERENCE MEDWATCH MW5061596. (B)(4). "TRANSWARMER WOULD NOT ACTIVATE/WARM. HAD TO GRAB ANOTHER THAT DID ACTIVATE TO WARM MATTRESS FOR PREEMIE BABY. THIS IS THE 2ND TIME THIS HAS HAPPENED WITH THIS EXACT PRODUCT. STAFF DIDN'T KEEP FIRST TRANSWARMER FOR REPORTING INFO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467596 TRANSWARMER TRANSWARMER FMT COOPERSURGICAL, INC. 20421 IJ459

    Patients

    Seq Age Sex Outcome Treatment
    1 Other