BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL INNERCOOL STX SURFACE SYSTEM

    MDR report key: 17941178 · Received October 16, 2023

    Report

    Report Number
    3010617000-2023-00872
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    FOH
    PMA / PMN Number
    K101589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INNERCOOL STX SURFACE SYSTEM (120V) (SN (B)(6)) INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED TO A ZOLL SERVICE DEPOT FOR EVALUATION. THE DEVICE WAS INVESTIGATED AND SERVICED BY GENTHERM AND THE BIOMED AT THE CUSTOMER SITE. THE FAILED CIRCUIT BOARD WAS REPLACED TO REMEDY THE BLANK/UNRESPONSIVE DISPLAY ISSUE. THE SYSTEM IS BACK IN SERVICE. SINCE THE ISSUE WERE RESOLVED, SERVICE WAS NOT REQUIRED TO BE PERFORMED BY ZOLL.

    Description of Event or Problem · 0

    SAMANTHA DAVIS CALLED FROM WOMEN'S HOSPITAL IN BATON ROUGE, LA TO REPORT AN INNERCOOL STX SURFACE SYSTEM (120V) (SN (B)(6). THAT ISN'T WORKING. THIS IS A NEW SITE, AND SHE'S ON SITE DOING IN-SERVICING FOR THE FIRST TIME BEFORE THEIR GO-LIVE THIS WEEK. SHE REPORTED THAT WHEN TURNING THE DEVICE ON, SHE'S GETTING A GREEN LIGHT, BUT THE DISPLAY IS BLACK. THE ZOLL CLINICAL FIELD EDUCATOR GAVE HER THE GENTHERM PHONE # FOR TROUBLESHOOTING. SHE CALLED GENTHERM AND THEY TOLD HER IT WAS A "FAULTY DISPLAY CIRCUIT BOARD" AND THAT IT NEEDED TO GO TO BIOMED FOR REPAIR. SHANE IN BIOMED AT WOMAN'S HOSPITAL BATON ROUGE CALLED GENTHERM AND WAS ABLE TO REPLACE THE SMALL CLASS CIRCUIT BULB AND THE MACHINE WAS OPERATIONAL. HOWEVER, TWO DAYS LATER, DURING TRAINING TO THE NURSING STAFF, THE SAME ISSUE OCCURRED WHEN THE CONSOLE WAS POWERED ON. NONE OF THE BUTTONS WOULD WORK. THE GENTHERM TECH EXPLAINED THAT IT WAS A FAULTY CIRCUIT BOARD AND PUT IN A REQUEST TO OVERNIGHT THE HOSPITAL A NEW CIRCUIT BOARD FOR REPLACEMENT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704963 ZOLL INNERCOOL STX SURFACE SYSTEM THERMAL REGULATING SYSTEM FOH ZOLL CIRCULATION 8700-00836-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown