BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1522245 · Received October 28, 2009

    Report

    Report Number
    2021710-2009-00047
    Event Type
    Malfunction
    Date Received
    October 28, 2009
    Date of Event
    September 10, 2009
    Report Date
    October 28, 2009
    Manufacturer
    CAREFUSION 207, INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 TECHNICIAN. THE CAREFUSION TECHNICAL SUPPORT SPECIALIST IN CONJUNCTION WITH THE END USER IDENTIFIED A WORN 3 OHM DRIVER ASSEMBLY AS THE MOST LIKELY ROOT CAUSE IN THIS EVENT. THE USER FACILITY BIOMED TECHNICIAN PERFORMED A 4 K PM (PREVENTATIVE MAINTENANCE) ON THE DEVICE WHICH INCLUDES THE 3 OHM DRIVER REPLACEMENT. UPON THE 3 OHM DRIVER ARRIVAL TO THE FACTORY, THE REPORTED FAILURE WAS VERIFIED BY THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN. HOWEVER THE FAILURE ANALYSIS LAB TECHNICIAN WAS NOT ABLE TO DETERMINE WAS CAUSED THE DIAPHRAGM TO TEAR. IN CONCLUSION, WE HAVE IDENTIFIED THE FOLLOWING, BASED ON THE DEVICE BEING 90 HRS AWAY FROM ITS SCHEDULED 4K PM, THIS FAILURE WAS THE RESULT OF THIS DEVICE REQUIRING A PM. IN ADDITION, IT IS POSSIBLE THAT THE USER FACILITY CLEANING PROCESS ACCELERATED THE 3 OHM DRIVER DETERIORATION.

    Description of Event or Problem · 1

    (B)(4) "EVENT DESC: HIGH OSCILLATION FREQUENCY PARAMETERS WERE INCREASED THROUGHOUT PT CARE BECAUSE THERE WAS NO IMPROVEMENT IN THE PT'S CONDITION. THERE WAS PERIODIC UNUSUAL NOISE OBSERVED. VENTILATOR REMOVED FROM PT. LARGE TEAR IN BELLOWS WAS DISCOVERED AT THIS POINT. THERE WAS NEVER AN ALARM INDICATING VENTILATOR WAS FUNCTIONING IMPROPERLY." "MANUFACTURER RESPONSE (AS PER REPORTER) FOR HIGH FREQUENCY OSCILLATOR VENTILATOR, HFOV-B". "CALLED VENDOR AND INFORMED THEM OF THE EVENT. THEY SUGGESTED UTILIZING A DIFFERENT CLEANING PROCESS THAN WAS CURRENTLY IN USE. THIS IS NOT SATISFACTORY BECAUSE IT STILL SHOULD HAVE DETECTED THE TEAR AND ALARMED. NOTE: THE PART WAS WITHIN A FEW MONTHS OF ITS RECOMMENDED REPLACEMENT DATE, BUT HAD NOT EXCEEDED THE MFR'S REPLACEMENT INTERVAL." "DEVIC USAGE PROBLEM: DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT WAS SUPPOSED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 207, INC 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other FROM THE USER FACILITY MEDWATCH REPROT REC'D| THE FOLLOWING MEDICAL PRODUCT INFO WAS COPIED| MIXTURE (HELIUM) WAS BEING USED."| FROM FDA ON 09/30/2009. "AN ALTERNATIVE GAS