BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1399907 · Received May 28, 2009

    Report

    Report Number
    2021710-2009-00019
    Event Type
    Malfunction
    Date Received
    May 28, 2009
    Date of Event
    April 28, 2009
    Report Date
    May 28, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE EVALUATIONS PERFORMED BY BOTH THE CARDINAL HEALTH FIELD SERVICE REP AND CARDINAL HEALTH SERVICE DEPARTMENT. THE CARDINAL HEALTH FIELD SERVICE REP WENT ON SITE TO EVALUATE THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED PROBLEM OF THE OSCILLATOR NOT STARTING. AS A PRECAUTION, THE FIELD SERVICE REP PERFORMED A 7 YEAR PREVENTIVE MAINTENANCE WHICH INCLUDED THE REPLACEMENT OF THE DRIVER POWER MODULE ASSEMBLY. THE DEVICE WAS THEN RUN THROUGH A COMPLETE CHECKOUT TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. UPON RECEIPT AT THE FACTORY, THE CARDINAL HEALTH SERVICE DEPARTMENT TECHNICIAN RAN THE DRIVER POWER MODULE ASSEMBLY FOR OVER 4 HOURS AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS, WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. IN 2009, "UNIT CAME TO HIM WITH THE COMPLAINT THAT THE SYSTEM PRESSURIZES BUT DOES NOT START, AND HAS NOT HAD 7 YEAR PM". THE NEXT DAY, "[NAME REMOVED] CALLED TO REPORT THAT SINCE THIS VENT "FAILED" ON A PATIENT, HE WOULD LIKE TO HAVE A SERVICE CALL". THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CARDINAL HEALTH MEDICAL PRODUCTS FROM THE FDA ON THE FOLLOWING MONTH AND THEN FORWARDED TO CARDINAL HEALTH, INC THE SAME DAY. "EVENT DESC: STAFF REPORT: "VERY SICK BABY ON HFOV WHEN OSCILLATOR STOPPED AND COULDN'T BE RESTARTED. SHE HAD TO BE HAND VENTILATED WHILE NEW VENT WAS FOUND AND RECALLED. BABY DIDN'T TOLERATE HAND VENT WELL AND HAD DECREASED SATURATIONS WHEN BACK ON NEW VENT. INFANT HAS SEVERE PULMONARY HYPERTENSION, UNCLEAR IF WORSENING RESPIRATORY CONDITION DUE TO VENTILATION ISSUES"." "CLINICAL ENGINEER DOCUMENTED A PROBLEM WITH THE POWER MODULE WHICH FAILED IN USE CAUSING THE PROBLEM. THE SAME FAILURE SITUATION COULD BE REPRODUCED IN THE LAB BY THE TECHNICIAN UPON REVIEW. THE OSCILLATOR WAS CURRENT WITH ALL PREVENTATIVE MAINTENANCE. THE DEVICE WAS A SENSORMEDICS 3100A OSCILLATOR." "DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO". "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other