BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1191444 · Received September 25, 2008

    Report

    Report Number
    2021710-2008-00082
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 24, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). CONNECTOR TO ALARM SPEAKER WAS LOOSE. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP EVALUATED THE DEVICE AND WAS ABLE TO VERIFY THAT THE DEVICE WAS NOT AUDIBLY ALARMING, HOWEVER, VISUAL ALARMS WERE WORKING. THE FIELD SERVICE REP IDENTIFIED THAT THE MAIN HARNESS (P/N 766593) ALARM CONNECTOR TO 45 SECOND ALARM SPEAKER (P/N 19059) WAS LOOSE CAUSING THE REPORTED EVENT. THE CARDINAL HEALTH FIELD SERVICE REP RECONNECTED THE MAIN HARNESS TO THE 45 SECOND ALARM SPEAKER AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY BIOMED. "[NAME REMOVED] REPORTS THAT 3100A TMA24527 HAS A PROBLEM WITH "ALARMS". THE ALARMS DO NOT SOUND. THEY THOUGHT IT WAS THE 9V BATTERY, BUT EVEN AFTER IT WAS REPLACED, THERE ARE NO AUDIBLE ALARMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA