BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130PA

    MDR report key: 17122628 · Received June 13, 2023

    Report

    Report Number
    8030229-2023-03574
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 12, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921117415
    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 (BME) REPORTED THAT THE NURSES ARE STATING THAT THE GZ TELEMETRY TRANSMITTER IS NOT ALARMING LOW BATTERY AT THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THEY NEVER GET AN ALARM, AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A GZ TELEMETRY TRANSMITTER AND NOT BEING USED IN HI-Q VIEW. 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. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: B2 D4 LOT NUMBER & EXPIRATION D6A - D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G5 G7 H2 H7 H9 THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. A2 - A6 B6 - B7 D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 05/17/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 05/30/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 06/13/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. CENTRAL NURSE'S STATION MODEL: NI SN: NI

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE STATING THAT THE GZ TELEMETRY TRANSMITTER IS NOT ALARMING LOW BATTERY AT THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THEY NEVER GET AN ALARM, AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A GZ TELEMETRY TRANSMITTER AND NOT BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED. SERVICE PERFORMED AND INVESTIGATION CONCLUSION: NIHON KOHDEN RECEIVED THE DEVICE ON 06/13/2023. NIHON KOHDEN REPAIR CENTER EVALUATED THE UNIT ON 06/22/2023 AND COULD NOT DUPLICATE THE COMPLAINT. THE UNIT WAS EVALUATED AGAIN ON 08/28/2023 AND THE COMPLAINT COULD NOT BE DUPLICATED, HOWEVER, RC ALSO FOUND A RATTLING NOISE COMING FROM INSIDE THE UNIT. IT IS UNCLEAR IF THE RATTING NOISE IS RELATED TO THE ISSUE. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT IT IS 2 YEARS OLD AND HAS NO OTHER COMPLAINTS. A DEFINITIVE ROOT CAUSE FOR THE BATTERY ALARM ISSUE COULD NOT BE DETERMINED SINCE THE COMPLAINT COULD NOT BE DUPLICATED; HOWEVER, BASED ON REVIEW OF SIMILAR COMPLAINTS FROM THE CUSTOMER, POSSIBLE CAUSE IS LIKELY RELATED TO THE TYPE OF BATTERY THAT THE CUSTOMER WAS USING AT THE TIME. REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY SHOWS SEVERAL SIMILAR COMPLAINTS UNDER THE FOLLOWING TICKETS: (B)(4). THIS ISSUE OF 'NO ALARM FOR LOW BATTERY' FOR THIS CUSTOMER WAS INVESTIGATED BY NIHON KOHDEN CORPORATION (NKC) WHICH CONCLUDED ON (B)(6) 2023. THE ISSUE WAS CONFIRMED THROUGH DEVICE LOGS FROM TICKET 167001 AND FOUND TO BE DUE TO THE CUSTOMER USING BATTERIES NOT RECOMMENDED FOR USE WITH THE GZ TRANSMITTER. FROM THE DEVICE LOGS, NKC FOUND THAT THE DEVICE MOST LIKELY SHUT DOWN FROM POWER LOSS BEFORE IT COULD GENERATE COMMUNICATION OF THE LOW / WEAK BATTERY STATUS. THE GZ OPERATOR'S MANUAL RECOMMENDS USING MEDIPOWER ALKALINE BATTERIES OR PANASONIC NIMH BATTERIES. NK FIELD SUPPORT ENGINEER / ACCOUNT MANAGER REPORTED THAT THE CUSTOMER HAS SWITCHED FROM USING PROCELL CONSTANT TO PROCELL INTENSE BATTERIES. THIS WILL CONTINUE TO BE MONITORED BY NK. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. ATTEMPT #1 05/17/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 05/30/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 06/13/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. CENTRAL NURSE'S STATION MODEL: NI SN: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE STATING THAT THE GZ TELEMETRY TRANSMITTER IS NOT ALARMING LOW BATTERY AT THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THEY NEVER GET AN ALARM, AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A GZ TELEMETRY TRANSMITTER AND NOT BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE STATING THAT THE GZ TELEMETRY TRANSMITTER IS NOT ALARMING LOW BATTERY AT THE CENTRAL NURSE'S STATION (CNS). THEY STATED THAT THEY NEVER GET AN ALARM, AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A GZ TELEMETRY TRANSMITTER AND NOT BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409685 GZ-130PA TRANSMITTER DRT NIHON KOHDEN CORPORATION GZ-130PA NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CENTRAL NURSE'S STATION.| CENTRAL NURSE'S STATION.