BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ARCTICGEL PADS

    MDR report key: 19423626 · Received May 30, 2024

    Report

    Report Number
    1018233-2024-03125
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 10, 2024
    Report Date
    May 20, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE "IMPROPER DESIGN CONSIDERATION OR MATERIAL SELECTION". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. THE DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE PRODUCT CATALOG NUMBER AND LOT NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY AWARE OF THE PAD ISSUE IN THE JHN NEUROSENSORY INTENSIVE CARE UNIT (NICU). THEY CAME UPON TWO MORE SETS AND WITH THE SAME ISSUE THIS WEEK ON 9SE. THESE PADS DID NOT STICK EITHER, PEELED BACK ON TO THEMSELVES ON SEVERAL PADS AND AS THE WATER TEMPERATURES FLUCTUATED, THE GEL CAME OFF THE PADS AND ON TO THE PATIENT, ALMOST IN A MELTING FASHION. THEY WERE NOT SURE IF THERE HAS BEEN A DIFFERENT MANUFACTURER OVER THE LAST FEW YEARS AND THE PADS HAVE BEEN GETTING WORSE AND WORSE THAT WAS MATERIAL COMING OFF AROUND THE HOSES AND THEN PADS NOT STICKING TO THE PATIENT, BUT THIS WAS THE WORST CONDITION THEY HAVE SEEN THEM. THEY CONCERNED SINCE IT WAS TWO DIFFERENT UNITS AND BUILDINGS AND MOST LIKELY TWO DIFFERENT LOTS. THE PICTURE OF THE BELOW WAS PEEL BACK FROM THE PADS ON 9SE, BUT THEY DID NOT HAVE THE LOT NUMBER OF THESE PADS. OTHER PICTURES BELOW WERE THE PADS FROM THE JHN NEUROSENSORY INTENSIVE CARE UNIT (NICU) BEING HELD TOGETHER, AND THE PACKAGING, LOT #NGHY5076 . PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10MAY2024, BIOMED SPOKE TO ARCTIC SUN SUPPORT AND THERE WAS NO NEED TO SEND IN DEVICE. THE PADS WERE AFFECTED. THE PADS WERE REMOVED FROM PATIENT AND NEW PADS DELIVERED BY REPRESENTATIVE. BOTH PATIENTS AFFECTED WHEN THROUGH TWO SETS OF PADS AND THEY COMPLETED THERAPY ON THE SAME DEVICE BUT DIFFERENT PADS. PATIENT DID NOT ADEQUATELY COOL UNTIL THE PAD PROBLEM WAS DETECTED AND THE PADS WERE SWITCHED OUT. THERE ARE 4 SETS OF PADS WERE DEFECTIVE. THE PROBLEM OCCURRED THE ENTIRE COOLING CYCLE FOR ALL PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108332 UNKNOWN ARCTICGEL PADS ARCTIC GEL PADS DWJ MEDIVANCE, INC. ¿ 1725056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other