BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STX SURFACE COOLING

    MDR report key: 8972374 · Received September 6, 2019

    Report

    Report Number
    3010617000-2019-00780
    Event Type
    Injury
    Date Received
    September 6, 2019
    Report Date
    August 16, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    FOH
    PMA / PMN Number
    K231182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED B5 (DESCRIBE EVENT OR PROBLEM), D1 (BRAND NAME), D2 (COMMON DEVICE NAME), D3 (MANUFACTURER NAME), D4 (MODEL #, CATALOG # AND PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #), G1 (CONTACT OFFICE - MANUFACTURING SITE), AND G4 (PREMARKET IDENTIFICATION).

    Description of Event or Problem · 0

    DURING THE TEMPERATURE MANAGEMENT THERAPY USING THE STX SURFACE COOLING PAD SET (LOT #UNKNOWN), THE PATIENT DEVELOPED BLISTERS. THE CUSTOMER MENTIONED THAT THE BLANKETS REMAINED ON THE PATIENT THROUGHOUT THE COOLING AND REWARMING PROCESS, TOTALING 48 HOURS. THE NURSE WAS UNSURE IF SKIN CHECKS WERE PERFORMED DURING TREATMENT.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. BASED ON MEDICAL SAFETY ASSESSMENT, THE EVENT WAS NOT SERIOUS BECAUSE IT DID NOT MEET ANY CRITERIA OF SERIOUSNESS PER REGULATIONS (DID NOT LEAD TO DEATH, WAS NOT LIFE-THREATENING, DID NOT RESULT IN A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION, DID NOT REQUIRE IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION, AND DID NOT RESULT IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION). DUE TO THE RELEVANT TIME AND THE EVENT LOCATION IN PREDISPOSED PATIENT, THE EVENT OF BLISTERS FROM THE BLANKET SYSTEM WAS PROBABLY RELATED TO THE INNERCOOL STX SURFACE SYSTEM PADS. IN IFU, IT LISTED THAT THE METHOD OF TEMPERATURE CONTROL PROVIDED BY ALL HYPER-HYPOTHERMIA UNITS PRESENTS THE DANGER OF HEATING OR COOLING BODY TISSUES, PARTICULARLY THE SKIN, TO A POINT WHERE THEY ARE INJURED, I.E., BURNS OR FROSTBITE, RESPECTIVELY.

    Description of Event or Problem · 1

    DURING SURFACE PAD SYSTEM TARGET TEMPERATURE MANAGEMENT THERAPY, CUSTOMER REPORTED THAT A PATIENT DEVELOPED BLISTERS FROM THE INNERCOOL STX SURFACE SYSTEM (120V) SERIAL #UNKNOWN. CUSTOMER ADDED THAT THE BLANKETS REMAINED ON THE PATIENT THE COOLING AND REWARMING PROCESS FOR A TOTAL OF 48 HRS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766720 STX SURFACE COOLING CIRCULATING-FLUID WHOLE-BODY HEATING/COOLING SYSTEM PAD, SINGLE-USE FOH ZOLL CIRCULATION, INC. L/XL PAD SET UNKNOWN
    766721 STX SURFACE COOLING CIRCULATING-FLUID WHOLE-BODY HEATING/COOLING SYSTEM PAD, SINGLE-USE FOH ZOLL CIRCULATION, INC. L/XL PAD SET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other