BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1302170 · Received December 5, 2008

    Report

    Report Number
    2021710-2008-00100
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Date of Event
    November 4, 2008
    Report Date
    December 3, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)] DID NOT SUBMIT A USER FACILITY/DISTRIBUTOR REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)].THE FOLLOWING INFORMATION CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH RAN THE DEVICE FOR 48 HOURS AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. THE DEVICE MEETS ALL FACTORY SPECS AND NO ANOMALIES WERE FOUND. AT THIS TIME NO COMPONENT AND SYMPTOM TREND HAS BEEN IDENTIFIED AND THIS EVENT IS CONSIDERED TO BE AN ISOLATED INCIDENT. THE ALLEGED FAULTY DEVICE WILL BE SCRAP. A REPLACEMENT DEVICE WAS SENT TO THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)] ON SALES ORDER.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECHNICAL SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A HILL-ROM (THIRD PARTY SERVICE COMPANY) SERVICE TECH. "[NAME REMOVED] CALLED TO REPORT THAT THIS BLENDER IS NOT PASSING THE BYPASS ALARM TEST. WHEN DISCONNECTING EITHER THE AIR OR OXYGEN, THERE IS NO AUDIBLE ALARM SOUNDING. THE BLENDER DOES PASS THE "LEAK TEST" HOWEVER, I WILL SEND HIM A REPLACEMENT BLENDER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73 LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA