BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1024218 · Received March 27, 2008

    Report

    Report Number
    2021710-2008-00020
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT. SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE STATUS OF THE PATIENT. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. 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 DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY ALARM BOARD ASSEMBLY. THE CARDINAL HEALTH FIELD SERVICE REP. REPLACED THE AFFECTED COMPONENT AND RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT IT MEETS FACTORY SPECIFICATIONS. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED AND STATED THAT THE RT SAID THAT THE ALARM SILENCE BUTTON ISN'T WORKING CORRECTLY. HE STATED THAT THE RT SAID THAT THE ALARM SILENCE SEEMED TO STAY ON FOR OVER 2MINS, AND AT ONE POINT, IT SEEMED LIKE IT WAS SILENCED CONTINUOUSLY. HE WAS NOT ABLE TO DUPLICATE THE PROBLEM, THE ALARM SEEMED TO ONLY SILENCE FOR THE 45SECONDS. HE WAS ABLE TO GET THE RT THAT SAW THE PROBLEM AND HAVE THEM SHOW HIM HOW THEY HAD IT SETUP ETC. THEY BOTH WEREN'T ABLE TO DUPLICATE THE PROBLEM, BUT THE RT WAS VERY CONCERNED BECAUSE THEY SAW IT DOING THIS ON A PATIENT, AND DOESN'T' FEEL COMFORTABLE USING THE UNIT. NO HARM OR COMPROMISE TO THE PATIENT, THEY JUST SWAPPED THE UNIT OUT. I RECOMMENDED A SERVICE CALL. WOULD RECOMMEND THEY REPLACE THE ALARM BOARD. GAVE HIM PRICING FOR THE ALARM BOARD AND GAVE HIM LABOR AND TRAVEL RATE. HE WILL HAVE PO# READY WHEN THE FIELD REP CALLS HIM."

    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 UNK