BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS PRISMA 2K

    MDR report key: 3766001 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00018
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    January 10, 2007
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Adverse Event
    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: THE RETURNED DEVICE WAS EXAMINED. IT WAS DETERMINED THAT THE INSTRUMENT BATTERY DOOR WAS NOT LOCKED CORRECTLY AS DESCRIBED IN THE USER MANUAL. A CORRECTLY LOCKED INSTRUMENT WOULD CAUSE A DEFORMATION OF THE HOUSING IF THE BATTERY DOOR WOULD BE OPENED WITH FORCE, AND NO DEFORMATION WAS OBSERVED. IT WAS FOUND THAT THE LOCKING BOLT WAS UNABLE TO ENTER THE HOLE IN THE CASING TO PROVIDE THE LOCKING FUNCTION. THE HOLE WAS DAMAGED DURING (POST MANUFACTURING) WHICH DISTORTED THE HOLE AND PREVENTED THE LOCK FORM FUNCTIONING PROPERLY. THE SAFETY BOARD DETERMINED: PRISMA 2K WAS NOT CORRECTLY LOCKED DUE TO A USER HANDLING ISSUE; PRISMA 2K DOES NOT HAVE SIGNS OF BITE MARKS AS THERE WAS NO DEFORMATION OF THE HOUSING; NO CORRECTIVE ACTIONS ARE NECESSARY SINCE THE BATTERY DOOR WAS NOT LOCKED CORRECTLY AS DESCRIBED IN THE USER MANUAL.

    Description of Event or Problem · 1

    INFANT PATIENT IN (B)(6) ABLE TO OPEN BATTERY DOOR ON PRISMA 2K HEARING AID AND SWALLOWED THE BATTERY. MOTHER TOOK PATIENT TO THE HOSPITAL AND THE PATIENT PASSED THE BATTERY WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667411 SIEMENS PRISMA 2K BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR