BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS PRISMA 2K

    MDR report key: 3766004 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00015
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 21, 2005
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC
    Product Code
    ESD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION:SIEMENS SENT A NOTICE LETTER TO DISPENSERS IN DECEMBER 2005 FURTHER INSTRUCTING DISPENSERS HOW TO CHECK THE BATTERY DOOR LOCK. SIEMENS RE-DESIGNED THE BATTERY DOOR LOCKING MECHANISM BY ADDING A BOLT FOR ALL SHIPMENTS IN THE UNITED STATES DISTRIBUTED AFTER 01/18/2006.

    Description of Event or Problem · 1

    THE LOCKING BOLT ON BTE PRISMA 2K CONVERSION KITS WAS ASSEMBLED IN WRONG DIRECTION, PREVENTING THE LOCKING OF THE BATTERY DOOR. THIS WAS FOUND ON 6 BEIGE CONVERSION KITS OUT OF 15 BEIGE CONVERSION KITS FROM OUR STOCK. NO KNOWN COMPLAINTS FROM THE FIELD FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667412 SIEMENS PRISMA 2K BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1