BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 4152576 · Received October 6, 2014

    Report

    Report Number
    9615050-2014-05499
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z-0069-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE TOUCHSCREEN RESPONDED WHEN PRESSED AND THE KEY ALIGNMENT WAS GOOD. THIS WAS PROBABLY DUE TO THE CUSTOMER CONTACT REPORTED CLEANING AND CALIBRATING THE TOUCHSCREEN PRIOR TO RETURNING TO THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED SEVERAL BUTTON ID: INVALID ALARM CODES. FURTHER TESTING FOUND EVIDENCE OF CORROSION ON THE LOWER LEFT, RIGHT BOTTOM AND FRONT BEZEL. THE PROBABLE CAUSE OF THE DEVICE TOUCHSCREEN NOT RESPONSIVE WAS DUE TO CONTAMINATION FROM FLUID INGRESS WHICH ALTERED THE CHARACTERISTICS OF THE TOUCHSCREEN. AS INDICATED, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED AND THE DEVICE FAILED THE BATTERY RECONDITIONING AND SHOWS THE MESSAGE SERVICE BATTERY ALARM. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "BUTTONS DO NOT WORK." NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE TOUCHSCREEN DID NOT RESPOND WHEN PRESSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622147 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK