BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 4239211 · Received October 31, 2014

    Report

    Report Number
    9615050-2014-05851
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING IT WAS FOUND AT POWER ON THE DEVICE DISPLAYED E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE. THIS WAS DUE TO THE PIEZO ALARM ASSEMBLY. THE DEFECTIVE PIEZO ALARM ASSEMBLY WAS RETURNED TO SUPPLIER [PROJECTS UNLIMITED AND SUNWAY FOR ANALYSIS. PROJECTS UNLIMITED PUI FOUND A COLD SOLDER ON THE INDUCTOR OF THE PRINTED CIRCUIT BOARD OF THE PIEZO ASSEMBLY WHICH DISABLED THE OPERATION OF THE PIEZO. THE PROBABLY CAUSE OF THE COLD SOLDER JOINT IS DUE TO POOR WORKMANSHIP BY THE SUPPLIER. THE PIEZO ALARM ASSEMBLY IS RESPONSIBLE FOR GENERATING AUDIBLE ALARM TOMES IN THE PLUM A+ DEVICE. ERROR CODE E301 WILL OCCUR INT HE DEVICE WATCHDOG DETECTS AN AUDIBLE ALARM CIRCUIT FAILURE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CTR FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED E380 (TUBING SENSOR FAILURE). THIS IS NOT A REPORTABLE MALFUNCTION; HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR AT POWER ON THE DEVICE DISPLAYED E301 (AUDIO ALARM FAILURE) WITH NO AUDIBLE ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698369 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE LIST# 12097| SN (B)(4)