BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1853089 · Received September 22, 2010

    Report

    Report Number
    2021710-2010-00042
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A (B)(4) TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. (B)(4) ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE ALLEGED FAULTY ALARM BOARD FOR EVAL. AS OF THE DATE OF THIS REPORT THE ALLEGED FAULTY ALARM BOARD HAS NOT BEEN RECEIVED BY (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A (B)(4)TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REP. "[NAME REMOVED] CALLED AND UNIT WAS SENT TO HIM AFTER INCIDENT WHILE ON A PT. WHILE THE STAFF WAS WEANING DOWN THE MAP THEY NOTICED THE PRESSURE ALARMS WERE NOT GENERATED ON THE LOW THUMBWHEEL AS IT SHOULD, LOW THUMBWHEEL WAS SET AT 9 AND DID NOT ACTIVATE UNTIL 3. THEY TOOK THE VENT OFF OF THE PT, NO PT COMPROMISE, AND DETERMINED THAT THE UNIT WOULD NOT GENERATE A HIGH MAP ALARM AS IT SHOULD EITHER, UPPER ALARM SET AT 15 AND DID NOT TRIGGER UNTIL 18. [NAME REMOVED], A FACTORY TRAINED BIOMED, LOOKED AT UNIT AND CAN DUPLICATE THE COMPLAINT. ADVISED THAT SINCE IT IS OCCURRING WITH BOTH UPPER AND LOWER THUMBWHEEL ALARMS THAT THE ALARM BOARD SHOULD BE REPLACED. GAVE P/N (B)(4) AND ISSUED RGA#(B)(4)TO HAVE ALARM BOARD COME TO PS FOR QA ANALYSIS. GAVE UPS ACCOUNT NUMBER AND PS ADDRESS."

    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 ASKU ASKU / ASKU