BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130P

    MDR report key: 16950217 · Received May 17, 2023

    Report

    Report Number
    8030229-2023-03562
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    May 2, 2023
    Report Date
    December 17, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K153707
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER WITH HI-Q VIEW WENT OFFLINE WITHOUT SHOWING A LOW BATTERY ALARM. BIOMED STATED THAT THE CUSTOMER WOULD LIKE NIHON KOHDEN TO REVIEW THE LOGS. NO PATIENT HARM WAS 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. D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI. ATTEMPT # 1: (B)(6) 2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WITH HI-Q VIEW WENT OFFLINE WITHOUT SHOWING A LOW BATTERY ALARM. THE BME STATED THAT THE CUSTOMER WOULD LIKE NIHON KOHDEN (NK) TO REVIEW THE LOGS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: NKC INVESTIGATED THIS ISSUE FOR THIS CUSTOMER. A REVIEW OF THE DEVICE LOGS, PACKET CAPTURE DATA, AND THE TYPE OF BATTERY USED BY THE CUSTOMER FOUND THAT THE CAUSE OF THE ISSUE WAS A COMBINATION OF PROLONGED BATTERY USAGE AND HIGH OPERATIONAL LOAD DUE TO COMMUNICATION ISSUES WITH THE WIRELESS ACCESS POINTS LEADING TO THE BATTERY BEING DRAINED FASTER THAN IT TAKES FOR THE DEVICE TO PRODUCE THE LOW BATTERY ALARM. NKC PLANS TO MAKE IMPROVEMENTS TO THE GZ ALARM BEHAVIOR IN A FUTURE DESIGN CHANGE PLAN AND PROVIDED THE NKC COMPLAINT# R50200A5-240072 AS A REFERENCE. NKC PLANS TO ADDRESS THIS ISSUE THROUGH SOFTWARE IMPROVEMENTS. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 B6 B7 D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE. **UDI RELATED DATA QUALITY UPDATES** CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM GZ-130PA TO GZ-130P. D2B DEVICE PRODUCT CODE: CORRECTED THE PRODUCT CODE FROM DRT TO MHX. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PI INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, APPLICABLE TO THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION OF THE FDA FORM 3500A.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER WITH HI-Q VIEW WENT OFFLINE WITHOUT SHOWING A LOW BATTERY ALARM. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE GZ TRANSMITTER WITH HI-Q VIEW WENT OFFLINE WITHOUT SHOWING A LOW BATTERY ALARM. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860717 GZ-130P TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-130P NA

    Patients

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