BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1267899 · Received November 11, 2008

    Report

    Report Number
    2021710-2008-00095
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 11, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE FOLLOWING INFORMATION CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A (B) (4) (THIRD PARTY SERVICE COMPANY) REP. THE (B) (4) (THIRD PARTY SERVICE COMPANY) SERVICE TECH EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED FAILURE OF DEVICE NOT ALARMING FOR LOW MAP. THUS NO ROOT CAUSE WAS DETERMINED. THE (B) (4) (THIRD PARTY SERVICE COMPANY) SERVICE TECH RAN THE DEVICE THROUGH A COMPLETE CALIBRATION AND CHECKOUT (SPI) TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. UPON COMPLETION, THE UNIT WAS RETURNED TO THE RENTAL POOL READY TO BE PLACED BACK INTO RENTAL SERVICE.

    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 RENTAL DEPT REP AND A USER FACILITY REP. "FORWARDED COMPLAINT FROM RENTALS. [NAME REMOVED] REPORTS THAT [NAME REMOVED] (SALES) CALLED IN TO RENTALS REPORTING A RENTAL VENT "FAILURE". COMPLAINT: "LOW MAP". HE REQUESTS A REPLACEMENT. [NAME REMOVED] EXPLAINS THAT ALL COMPLAINTS NEED TO GO TO TECH SUPPORT FIRST FOR TROUBLESHOOTING, BUT SHE WILL GO AHEAD AND REPLACE THE VENT FOR HIM. I CONTACTED [NAME REMOVED] AND HE EXPLAINS THAT THE VENT DOESN'T ALARM "LOW MAP" WHEN THE MAP FALLS BELOW THE LOW MAP THUMBWHEEL SETTING. HE STATES THAT HE DOESN'T KNOW IF ANYONE CHECKED THE "HIGH MAP" ALARM; HE JUST KNOWS THAT THE "LOW MAP" DIDN'T SOUND. THE RT NOTICED THIS DURING A SETTING CHANGE. I WILL FOLLOW UP WITH (B) (4). CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK