BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICOOL

    MDR report key: 7920765 · Received September 28, 2018

    Report

    Report Number
    1219702-2018-00034
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 28, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    DWJ
    PMA / PMN Number
    K071341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA RETRIEVED FROM THE DEVICE SHOWED THAT THERE WAS A HIGHER SURFACE TEMPERATURE THAN CORE TEMPERATURE, WHICH COULD INDICATE THAT THE HEATING LAMP WAS ON WHILE COOLING. THE DATA ALSO SHOWED AN ELEVATED LINE PRESSURE, WHICH COULD INDICATE THAT THE WRAP WAS TOO TIGHT ON THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE DOCTOR AT THE USER FACILITY REPORTED THAT A PATIENT WAS EXHIBITING SIGNS OF SUBCUTANEOUS FAT NECROSIS AND WAS REMOVED FROM THE CRITICOOL PRIOR TO THE COMPLETION OF A 72 HOUR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760449 CRITICOOL THERMAL REGULATING SYSTEMS DWJ BELMONT INSTRUMENT LLC

    Patients

    Seq Age Sex Outcome Treatment
    1