BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1359225 · Received March 24, 2009

    Report

    Report Number
    9610617-2009-00007
    Event Type
    Other
    Date Received
    March 24, 2009
    Manufacturer
    *
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT NOT RELEASED BY HOSP BUT WAS TESTED/INSPECTED BY THEIR BIOMED. HE TESTED UNIT WITH SETTINGS THEY KNEW THE OR USED AND THEY FOUND THAT THE THERMOFLATOR FUNCTIONED WITHIN SPECS; THERE WAS NO PROBLEM FOUND WITH THE UNIT. THE ALARM ACTIVATED WHEN IT WAS SUPPOSED TO. BIOMED STATED THAT THE SET PRESSURE WAS 15 AND THE FLOW AT 29. BIOMED STATED THAT IT WAS POSSIBLE THAT SOMEONE MADE AN ADJUSTMENT TO THE UNIT DURING PROCEDURE; HE ALSO BELIEVES THAT UNIT PROBABLY DID NOT ALARM WHEN IT HIT 30 BECAUSE IT DID NOT STAY THERE LONG ENOUGH (3-4 SECONDS) TO ACTIVATE THE ALARM. THE INSTRUCTION MANUAL SUPPORTS THE HOSPITAL'S CONTENTION: OVERPRESSURE ALARM - IF THE PT PRESSURE EXCEEDS THE SETPOINT BY 5MMHG FOR MORE THAN 5.0 SECONDS, AN AUDIBLE ALARM CONSISTING OF A SERIES OF 3 LONG BEEPS WILL SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * GCJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *