BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 4142936 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05207
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AT THE SERVICE CENTER FOR TESTING AND INVESTIGATION. DURING TESTING THE DEVICE POWERED ON AND PASSED THE SELF TEST. THE DEVICE PASSED THE POWER TEST SINCE IT CAN OPERATE ON BOTH AC AND DC POWER. THE DEVICE PERFORMED AND FAILED THE KEYPAD TEST SINCE NO AUDIBLE TONE WAS HEARD WHEN KEYS ON THE KEYPAD WERE PRESSED. IN ADDITION, THE DEVICE ALARMED FOR 09/018/001 (MOTOR_OVER_DELIVERY) WHILE PERFORMING THE PVT VOLUME ACCURACY TEST. THE ERROR CODE COULD NOT BE CLEARED AND THE DEVICE WAS INOPERABLE. THE ALARM WAS NOT AUDIBLE DURING THE ALARM CONDITION. THE DEVICE WAS DISASSEMBLED AND A VISUAL INSPECTION FOUND THAT THE BEEPER ASSEMBLY WAS INCORRECTLY SOLDERED. THE RED AND BLACK WIRES OF THE BEEPER ASSEMBLY WERE SOLDERED TO THE MOTOR ASSEMBLY BOARD. THE RED AND BLACK WIRES OF THE BEEPER ASSEMBLY WERE RESOLDERED TO THE BOTTOM PWA AT J206. THE DEVICE WAS NOW PRODUCING AN AUDIBLE ALARM AND THE KEY PAD TONE WAS AUDIBLE WHEN PRESSED. THE PVT KEYPAD TEST WAS PERFORMED AND COMPLETED THREE TIMES AS EXPECTED. THE PVT OPERATION TEST WAS PERFORMED AND EACH TEST WAS COMPLETED WITHIN SPECIFICATION. THE RESULT FOR PVT VOLUME ACCURACY TEST WAS 19.79 ML (SPEC: 19-21 ML). THE CUSTOMER COMPLAINT WAS CONFIRMED AND IS ATTRIBUTABLE TO THE DEVICE. THE ALARM AND KEYPAD TONES WERE NOT AUDIBLE. IN ADDITION, A 09/018/001 MALFUNCTION WAS OBSERVED. THE PROBABLE CAUSE WAS DUE TO A INCORRECT SOLDERING OF THE WIRES OF THE BEEPER ASSEMBLY. THE DEVICE WAS MANUFACTURED IN 2006 AND THIS IS THE FIRST TIME IT HAS BEEN RETURNED TO THE SERVICE CENTER. 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 THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WITH AN AUDIBLE TONE. IT WAS REPORTED THAT THE SPEAKER WAS NOT WORKING. THERE WERE NO REORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565307 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA