BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUECOOL

    MDR report key: 2838356 · Received June 14, 2007

    Report

    Report Number
    3004597813-2007-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2007
    Date of Event
    May 6, 2007
    Report Date
    May 16, 2007
    Manufacturer
    AQUEDUCT MEDICAL
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2007 - THE DEVICE WAS RECEIVED AT AQUEDUCT MEDICAL. THE DEVICE WAS RETURNED WITH A TAG SPECIFYING THAT THE DEVICE WAS COVERED WITH A BLANKET WHILE IN USE AT THE FACILITY. ON (B)(4) 2007 - THE DEVICE WAS DISASSEMBLED AND A FAILED POWER SUPPLY WAS IDENTIFIED. THE POWER SUPPLY WAS OPENED AND IT WAS CONFIRMED THAT A COMPONENT (CURRENTLY UNK) HAD SHORTED CAUSING BLACK SOOT WITHIN THE CHASSIS. ON 06/01/2007 - THE FAILED POWER SUPPLY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. ON 06/04/2007 - SPOKE WITH (B)(6), THE RISK MGR FROM THE REPORTING FACILITY REGARDING THE DEVICE BEING COVERED WITH A BLANKET DURING USAGE. SHE QUERIED HER STAFF AND CONFIRMED THAT THE DEVICE WAS INDEED COVERED BY A BLANKET DURING OPERATION. ON 06/04/2007 - THE SHIPPING CHECKLIST WAS REVIEWED AND CONFIRMED THAT THE USER MANUAL ACCOMPANIED THE DEVICE TO THE USER/PT. ON 06/04/2007 - A REVIEW OF THE DEVICE LABELING WAS PERFORMED. SPECIFICALLY, THE AQUECOOL USER MANUAL (PART NUMBER 32-0003-001 REVISION E) WHICH ACCOMPANIES EVERY DEVICE WAS REVIEWED. IT WAS CONFIRMED THAT SECTION 1, WARNINGS AND CAUTIONS APPROPRIATELY STATES: "COMPLETELY READ ALL DIRECTIONS IN THIS MANUAL BEFORE USING THE AQUECOOL DEVICE." IN ADDITION, THE FOLLOWING IS STATED: "DO NOT RESTRICT AIR FLOW BY BLOCKING AIR VENTS." ON 06/11/2007 - POWER SUPPLY INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    PT FOR ELECTIVE FACIAL SURGERY ON (B)(6) 2007. POST OPERATIVELY, THE PT WAS TO USE THE AQUECOOL MASK. ON (B)(6) 2007, THE UNIT BEGAN TO SMOKE AND WAS IMMEDIATELY UNPLUGGED. THE REP FROM THE RENTAL COMPANY REMOVED THE UNIT AND PROVIDED THE PT WITH A REPLACEMENT. ACCORDING TO THE REP, THE UNIT WAS RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUECOOL COOLING THERAPY DEVICE ILO AQUEDUCT MEDICAL 91-0001-001

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention