BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1845039 · Received September 13, 2010

    Report

    Report Number
    2021710-2010-00041
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (THIRD PARTY SERVICE COMPANY) DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY (B)(6) (THIRD PARTY SERVICE COMPANY). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION TECH SUPPORT SPECIALIST, THE CAREFUSION SERVICE DEPT. TECH AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE (B)(6) (THIRD PARTY SERVICE COMPANY) SERVICE TECH IN CONJUNCTION WITH THE CAREFUSION TECH SUPPORT SPECIALIST DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY AIR/O2 BLENDER. THE ALLEGED FAULTY AIR/O2 BLENDER WAS INITIALLY EVALUATED BY THE CAREFUSION SERVICE DEPT. TECH WHO WAS UNABLE TO REPRODUCE/VERIFY THE ALARM FAILURE. THE AIR/O2 BLENDER WAS THEN EVALUATED BY THE CAREFUSION FAILURE ANALYSIS LAB TECH. WHO WAS ABLE TO REPRODUCE THE ALARM FAILURE INTERMITTENTLY AND DETERMINED THAT THE ROOT CAUSE OF THE FAILURE WAS A DAMAGED ALARM REED PLATE PN: 01866. UNRELATED TO THE REPORTED EVENT, THE CAREFUSION FAILURE ANALYSIS LAB TECH FOUND THE FOLLOWING ADDITIONAL ISSUE; THE LOW O2 ALARM ACTIVATES AT 23 PSI INSTEAD OF AT 18 - 22 PSI DUE TO THE POPPET PN: 21984 BEING OUT OF CALIBRATION. THE CAREFUSION FACTORY SERVICE DEPT. OVERHAULED/REFURBISHED THE AIR/O2 BLENDER AND PLACED IT INTO REFURBISHED STOCK. (B)(6)(THIRD PARTY SERVICE COMPANY) WAS SHIPPED A REPLACEMENT AIR/O2 BLENDER TO REPAIR THE DEVICE AND RETURN IT TO THE RENTAL POOL READY TO BE PLACED BACK INTO RENTAL SERVICE. AT PRESENT, CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A THIRD PARTY SERVICE COMPANY REPRESENTATIVE. "[NAME REMOVED] CALLED TO REPORT THAT WHEN HE WAS DOING THE BLENDER CHECK, HE FOUND THAT WHEN THE DIAL IS SET TO 50%, THE BYPASS DOES NOT ALARM WHEN THE O2 IS DISCONNECTED. I WILL SEND HIM A REPLACEMENT BLENDER 24-767120. BLENDER SERIAL NUMBER IS: (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION 3100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA