BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSORMEDICS

    MDR report key: 2297769 · Received October 7, 2011

    Report

    Report Number
    2021710-2011-00076
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. (B)(4) REPORTED TO THE DISTRIBUTOR IN THE (B)(4), CAREFUSION (B)(4) RELAYED TO CAREFUSION (B)(4) AND RELAYED TO CAREFUSION (B)(4) VIA E-MAIL. (B)(4). CAREFUSION HAS CONTACTED OUR DISTRIBUTOR IN (B)(4), CAREFUSION (B)(4) AND ASKED THAT THEY SEND SOMEONE TO EVALUATE THE DEVICE, PROVIDE US WITH A COPY OF THEIR SERVICE REPORT DETAILING THEIR FINDINGS AND TO RETURN ANY PARTS REPLACED TO THE CAREFUSION FAILURE ANALYSIS LAB IN (B)(4) FOR EVAL. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS RESULTED IN ZERO LIKE FAILURES, THUS AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT (B)(4), CAREFUSION (B)(4) RELAYED TO CAREFUSION (B)(4) AND RELAYED TO CAREFUSION (B)(4) VIA E-MAIL. "THE DEVICE SUDDENLY STOPPED GIVING PRESSURES AND THE PT DESATURATED QUICKLY TO 70% IN LESS THAN A MINUTE. THE PRESSURE WAS INITIALLY SET TO 33.5 CM H2O, IT SUDDENLY DROPPED TO 10CM H2O WITHOUT ALARMING. THE PRESSURE DID NOT GO ABOVE 10CM H2O EVEN AFTER TRYING IT TO RAISE MANUALLY ON THE DEVICE."

    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 ASKU