BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRYMILL

    MDR report key: 3373025 · Received August 13, 2013

    Report

    Report Number
    1216795-2013-00002
    Event Type
    Malfunction
    Date Received
    August 13, 2013
    Date of Event
    April 24, 2013
    Report Date
    August 12, 2013
    Manufacturer
    BRYMILL CRYOGENIC SYSTEMS
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, WE (BRYMILL) SENT (B)(4), BRYMILL'S REPAIR TECHNICIAN, TO THE FACILITY WITH A REPLACEMENT CRY-AC-3 (B)(4). HE FOUND THE DEFECTIVE UNIT TO HAVE CRACKED PLASTIC COLLAR, AND A CRACKED PLASTIC COVER. ALSO THE UNITS COVER WAS NOT ON CORRECTLY, WHICH WOULD CAUSE THE LIQUID NITROGEN TO LEAK OR VENT OUT IF THE UNIT WAS TIPPED AS IT WOULD BE WHILE IN USE TREATING A PT. THE DAMAGE IS CONSISTENT WITH DAMAGE THAT OCCURS WHEN A UNIT IS DROPPED, WHICH WOULD CAUSE THE PLASTIC TO CRACK.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL, CALLED TO REPORT AN INCIDENT WITH THEIR CRY_AC3 SER# (B)(4), AS FOLLOWS... A P.A. WAS TREATING A PT WITH THE CRY-AC3, WHEN LIQUID NITROGEN SPRAYED OUT OF THE SIDE OF THE UNIT. THE P.A. REC'D SOME MINOR BURNS ON HER HAND, AND AN INCIDENT REPORT WAS FILLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388650 BRYMILL CRY-AC-3 GEH BRYMILL CRYOGENIC SYSTEMS B-800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention