BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1961500 · Received January 10, 2011

    Report

    Report Number
    2021710-2011-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 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

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION TECHNICAL SUPPORT SPECIALIST AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION TECH SUPPORT SPECIALIST IN CONJUNCTION WITH THE USER FACILITY'S BIOMED DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY ALARM BOARD ASSEMBLY. THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE ALARM BOARD ASSEMBLY AND VERIFIED THE COMPLAINT. THIS IS A KNOWN ISSUE THAT HAS ALREADY BEEN ADDRESSED; NO ADD'L INVESTIGATION/EVAL IS REQUIRED. CORRECTIVE OR PREVENTATIVE MEASURE INFO FOR THIS ISSUE RESIDES IN CORRECTIVE ACTION REQUEST (CAR) # (B)(4) AND ENGINEERING CHANGE ORDER (ECO) # (B)(4). THE USER FACILITY WAS SHIPPED A REPLACEMENT ALARM BOARD ASSEMBLY TO REPAIR THE DEVICE AND RETURN IT TO SERVICE.

    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 USER FACILITY REP. "[NAME REMOVED] CALLED AND WAS CHECKING THIS UNIT OUT AND SHE NOTICED THE 45 SECOND ALARM SILENCE BUTTON STAYS LIT ALL THE TIME. HAD HER CONFIRM THE ALARM SILENCE BUTTON IS NOT STICKING IN THE ON POSITION. SHE SAID IT WAS NOT. GAVE P/N 768588A AND PRICE. ALSO ISSUED RGA# (B)(4) TO HAVE DEFECTIVE BOARD COME BACK, GAVE UPS ACCOUNT NUMBER AS WELL FOR RETURN. NO PT INVOLVEMENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA