BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER MATTRESS

    MDR report key: 18012821 · Received October 26, 2023

    Report

    Report Number
    1216677-2023-00142
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 6, 2023
    Report Date
    December 19, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    UDI-DI
    00888937025767
    PMA / PMN Number
    K934631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC. BY CSI. MANUFACTURING RECORD REVIEW MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED BECAUSE THE COMPLAINT PRODUCT LOT/SERIAL NUMBER WAS NOT PROVIDED. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE INCOMING INSPECTION REPORT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. 1 COMPLAINT REPORTED A BURN TO AN INFANT, HOWEVER, THE COMPLAINT COULD NOT BE CONFIRMED. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. NOTE: VERIFIED WITH THE CUSTOMER PER CORRESPONDENCE THAT THIS DEVICE WAS USED WITH AN ADDITIONAL HEAT SOURCE, THE OMNI GIRAFFE BED DESPITE THE WARNING INDICATED ON THE DEVICE AND IFU: DO NOT APPLY AN ADDITIONAL HEAT SOURCE TO THE INFANT WHEN USING THIS PRODUCT. VERIFIED BOTH THE PRODUCT AND THE IFU STATE: DO NOT LEAVE ON SKIN LONGER THAN 10 MINUTES. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPER SURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED AND CAN NOT BE RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE DEVICE, THE PATIENT SUFFERED A BURN OF UNKNOWN DEGREE. THE PATIENT CONDITION IS UNKNOWN AS THEY WERE TRANSFERRED TO ANOTHER FACILITY. THE CUSTOMER STATED THAT THE DEVICE WAS USED IN CONJUNCTION WITH AN ADDITIONAL HEAT SOURCE. DEVICE WAS DISCARDED BY CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2023-00142 20421 TRANSWARMER 2023-10-0000176.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567778 TRANSWARMER MATTRESS REACTIVE-GEL HEATING PAD IMD COOPERSURGICAL, INC. 20421 UNKNOWN 00888937025767

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other