BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1912753 · Received November 12, 2010

    Report

    Report Number
    2021710-2010-00054
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    June 5, 2010
    Report Date
    June 5, 2010
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A (B)(4) TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED BACK. SHE STATED THAT IT MIGHT HAVE BEEN A MISTAKE ON THEIR PART STATING THAT THIS WAS A RENTAL UNIT. SHE STATED THAT SHE HAS THE BIOMED REPORT ON THIS ONE FOR THIS OCCURRENCE. SHE STATES THAT THE BIOMED CHECKED THE UNIT OUT AND FOUND THAT THE DDI [DRIVER DISPLACEMENT INDICATOR] WAS OUT OF CALIBRATION, SO THEY RECALIBRATED IT. THEY PERFORMED A PERFORMANCE VERIFICATION AND EVERYTHING CHECKED OUT FINE ALONG WITH THE ALARMS WORKING FINE. EXPLAINED TO HER THAT I WILL UPDATE THIS CALL WITH THAT INFORMATION." BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY IT APPEARS THAT THEY WERE UNABLE TO REPRODUCE THE INOP CONDITION OR THE NO AUDIBLE ALARM CONDITION. THE DDI [DRIVER DISPLACEMENT INDICATOR] CALIBRATION HAS NO EFFECT ON THE OPERATION OF THE DEVICE'S AUDIBLE ALARMS. AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY (B)(4) FROM THE FDA ON (B)(4) 2010. "TITLE: XXXXX. EVENT DESC: NO CHEST WIGGLE FROM VENT. VENTILATOR HAD STOPPED WORKING & THERE WAS NO AUDIBLE ALARM. VENTILATOR WAS REPLACED WITH FUNCTIONING HFOV. HEALTH PROFESSIONAL'S IMPRESSION. NO ADVERSE EVENT. NO HARM TO PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA Other ASKU