BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1207889 · Received October 16, 2008

    Report

    Report Number
    2021710-2008-00089
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON SEPTEMBER 22, 2008, CARDINAL HEALTH SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. ON OCTOBER 04, 2008, THE USER FACILITY REFUSED RECEIPT OF THE LETTER AND THE LETTER WAS RETURNED TO CARDINAL HEALTH UNOPENED. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CARDINAL HEALTH FIELD SERVICE REP. THE CARDINAL HEALTH FIELD SERVICE REP EVALUATED THE DEVICE AND WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE THUS WAS NOT ABLE TO IDENTIFY A ROOT CAUSE IN THIS ALLEGED EVENT. HOWEVER, DURING THE EVALUATION, THE FIELD SERVICE REP IDENTIFIED A LOOSE PATIENT CIRCUIT CAP DIAPHRAGM THAT NEEDED TO BE RESEATED. THE CARDINAL HEALTH FIELD SERVICE REP RESEATED THE LOOSE PATIENT CIRCUIT CAP DIAPHRAGM, PERFORMED A 2K PM AND RAN THE UNIT 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.

    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 REPRESENTATIVE. "CALLED TO GET A SERVICE CALL ON THIS UNIT. SHE STATES THAT THE RTS HAVE A COMPLAINT ON THIS UNIT. SHE JUST READ ME THE NOTE THAT THEY LEFT. I STATED THAT THE MAP WON'T CALIBRATE, WITH LIMIT MAXED OUT. SHE ALSO SAID THAT THE LOW PAW ALARM DOESN'T ALARM. THIS IS ALL THE INFORMATION SHE HAS, SHE THINKS THAT IT WAS WHEN THEY WERE TRYING TO SET THE UNIT UP BEFORE PATIENT. WILL DISPATCH SVC CALL. TOTAL SVC CONTRACT."

    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 DAYS