BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA REFURB 802.11

    MDR report key: 4190185 · Received September 18, 2014

    Report

    Report Number
    9615050-2014-05302
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 14, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE. THE PROBABLE CAUSE FOR THE 630 MALFUNCTION WAS DUE TO GREASE THAT LEAKED ONTO THE OPTO SENSOR. A SLOTTED OPTICAL INTERRUPTER SENSOR ONTO THE OPTO SENSOR. A SLOTTED OPTICAL INTERRUPTER SENSOR MONITORS A MECHANICAL FLAG COUPLED TO THE ROTATION OF THE LEAD SCREW WITH A FLAT EXTENSION. EACH REVOLUTION OPENS AND CLOSES THE SLOTTED OPTICAL PATH. THE CONNECTIONS TO THE SENSOR ARE COMBINED WITH THE MOTOR. THE GREASE THAT LEAKED ONTO THE OPTO SENSOR SHAFT MAY HAVE INTERFERED WITH SENSORS WHICH RESULTED IN A 630 MALFUNCTION (SCREW ROTATION ERROR). THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF AN E60 ALARM AND WILL NOT POWER ON. THESE ARE NOT REPORTABLE MALFUNCTIONS. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577664 LC PCA REFURB 802.11 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA