BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 15126903 · Received July 28, 2022

    Report

    Report Number
    3010617000-2022-00897
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 29, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT YET RECEIVED THE DEVICE IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THERMOGARD XP IVTM SYSTEM (SN (B)(6) DISPLAYED MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGE WAS CONFIRMED DURING FUNCTIONAL TESTING AND ARCHIVE DATA REVIEW. THE ROOT CAUSE OF THE MID:09 ERROR WAS DUE TO A DEFECTIVE AIR TRAP SENSOR BLOCK, LIKELY ATTRIBUTED FROM SALINE LIQUID FROM A LEAKING START-UP KIT (SUK). DURING VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE NOTED ON THE IVTM THERMOGARD CONSOLE. EVENT LOG DATA REVIEW WAS PERFORMED AND REVEALED SEVERAL MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGES; THUS, CONFIRMING THE REPORTED COMPLAINT. THE THERMOGARD CONSOLE FAILED THE INITIAL FUNCTIONAL TEST DUE TO THE MID:09 MESSAGE THAT WAS DISPLAYED AFTER SWITCHING ON THE DEVICE; THUS, CONFIRMING THE REPORTED COMPLAINT. THE AIR TRAP SENSOR BLOCK WAS REPLACED TO ADDRESS THE ERROR. FOLLOWING SERVICE, THE THERMOGARD CONSOLE PASSED ALL TESTS WITH NO ISSUES, AND READINGS WERE WITHIN THE SPECIFIED LIMITS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE IS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE THERMOGARD CONSOLE WITH SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER REPORTED THAT THE TOP CAP OF THE AIR TRAP OF THE START-UP KIT (SUK) (LOT #172206) WAS LEAKING. SALINE SOLUTION LEAKED INTO THE AIR TRAP SENSOR SYSTEM AND ON THE FLOOR. THE DWELL TIME WAS APPROXIMATELY 12 HOURS. THE THERMOGARD XP IVTM SYSTEM (SN (B)(4) DISPLAYED MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGE. THE SUK WAS REPLACED AND A NEW CONSOLE WAS USED TO COMPLETE THE THERAPY. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427088 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown