BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1081031 · Received July 18, 2008

    Report

    Report Number
    2021710-2008-00062
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)) DID NOT SUBMIT A USER FACILITY/DISTRIBUTOR REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE DISTRIBUTOR (THIRD PARTY SERVICE COMPANY)). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A (THIRD PARTY SERVICE COMPANY) REP AND THE SPI TEST DATA SHEET SUBMITTED TO CARDINAL HEALTH BY (THIRD PARTY SERVICE COMPANY). THE (THIRD PARTY SERVICE COMPANY) SERVICE TECH IN CONJUNCTION WITH THE CARDINAL HEALTH TECH SUPPORT SPECIALIST DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE'S ALARM BOARD WAS FAULTY. THE (THIRD PARTY SERVICE COMPANY) SERVICE TECH REPLACED THE ALARM BOARD AND RAN THE UNIT 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. CARDINAL HEALTH ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO (THIRD PARTY SERVICE COMPANY) FOR THE RETURN OF THE ALLEGED FAULTY ALARM BOARD FOR EVAL. AS OF THE DATE OF THIS REPORT, THE ALLEGED FAULTY ALARM BOARD HAS NOT BEEN RECEIVED BY CARDINAL HEALTH.

    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 (THIRD PARTY SERVICE COMPANY) REPRESENTATIVE. "[NAME REMOVED] IS WORKING ON THIS UNIT STILL AND HE NOTICED THAT THE BATTERY LOW LIGHT IS ON CONTINUOUSLY. UNIT WILL NOT ALARM IF POWER IS SHUT OFF. HE HAS A KNOWN GOOD BATTERY. GOING TO SEND HIM ALARM BOARD. THE ORDER NUMBER FOR THE REPLACEMENT ALARM BOARD AND RGA NUMBER FOR THE DEFECTIVE ONE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA