BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-140P

    MDR report key: 17484748 · Received August 8, 2023

    Report

    Report Number
    8030229-2023-03678
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 12, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921128244
    PMA / PMN Number
    K163459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THE CUSTOMER WILL SEND IN THE UNIT TO BE REPAIRED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN (NK) RECEIVED THE COMPLAINT DEVICE ON 07/27/2023. NK REPAIR CENTER (NK RC) EVALUATED THE COMPLAINT DEVICE ON 08/02/2023 AND DUPLICATED THE PROBLEM. NK RC OPENED THE UNIT AND SWAPPED THE SPEAKER FROM ANOTHER UNIT THAT WAS WORKING FINE. AFTER SWITCHING THIS, THEY GOT A SOUND FROM THE UNIT AND DETERMINED THAT THE PROBLEM WAS RELATED TO THE SPEAKER COMPONENT. THE CAUSE OF THE ISSUE WAS HARDWARE COMPONENT FAILURE OF THE SPEAKER. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT D9 DEVICE AVAILABLE FOR EVALUATION? G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE?. H3 DEVICE EVALUATED BY MANUFACTURER?. H10 ADDITIONAL MANUFACTURER NARRATIVE. MANUFACTURER REFERENCES # (B)(4) FOLLOW UP 001.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THE CUSTOMER WILL SEND IN THE UNIT TO BE REPAIRED. THERE WAS NO PATIENT INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM GZ-140PA TO GZ-140P. D2B PRODUCT CODE: CORRECTED THE PRODUCT CODE FROM DRT TO MHX. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM GZ-140PA TO GZ-140P. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM GZ-140PA TO GZ-140P. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A, PER THE FDA REQUEST. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS GZ TRANSMITTER IS NOT OUTPUTTING ANY SOUND. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683954 GZ-140P TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-140P NA 04931921128244
    2333886 GZ-140P TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-140P NA 04931921128244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CNS| CNS| CNS