BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130P

    MDR report key: 19192831 · Received April 26, 2024

    Report

    Report Number
    8030229-2024-04235
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 4, 2024
    Report Date
    October 30, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921117415
    PMA / PMN Number
    K153707
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2024, THE BIOMED REPORTED THAT THIS GZ TELEMETRY TRANSMITTER (MODEL: GZ-130PA, SERIAL NUMBER (B)(6) WOULD INTERMITTENTLY DROP ECG WAVEFORMS FROM THE GZ AND THE RNS WHILE IN USE WITH A PATIENT. THE BIOMED RAN THE UNIT ON A SIMULATOR AND THE SAME ISSUE OCCURRED, DROPPING ECG WAVES. THE CUSTOMER REQUESTED AN EXCHANGE. THERE WAS PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED, BUT NO REPORT OF PATIENT HARM, NO INJURY, NOR ANY ADVERSE EVENT, DUE TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: WE WERE UNABLE TO CONFIRM THE REPORTED ISSUE AS THE CUSTOMER INFORMED NK THAT THEY HAD LOST THE DEFECTIVE UNIT. DUE TO THE ORIGINAL UNIT NOT BEING RETURNED TO NIHON KOHDEN, REPAIR CENTER COULD NOT DETERMINE A POTENTIAL ROOT CAUSE. HOWEVER, REVIEW FROM A SIMILAR TICKET (B)(4) WITH ECG WAVEFORM DROPPING ISSUE SHOWS THAT A FAULTY ECG INPUT BOARD COULD BE A CONTRIBUTING FACTOR. TO RESOLVE THE ISSUE AN EXCHANGE UNIT (GZ-130PA, SERIAL NUMBER: (B)(6) WAS SHIPPED TO THE CUSTOMER. DEVICE HISTORY: A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: GZ-130PA, SERIAL NUMBER (B)(6) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. 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 CODED 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.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG WAVES ARE INTERMITTENTLY DROPPING FROM THE GZ TRANSMITTER AND AT THE REMOTE NURSE'S STATION (RNS) SO THE BIOMED SWAPPED IT OUT WITH ANOTHER GZ TRANSMITTER ON THE PATIENT, NO PATIENT HARM WAS REPORTED. BIOMED REPORTED THEY RAN THE DEVICE ON A SIMULATOR AND IT STILL CONTINUED TO DROP ECG WAVES. NO PHYSICAL DAMAGE TO THE UNIT REPORTED. BIOMED REQUESTED A WARRANTY EXCHANGE UNIT AND WILL RETURN THIS GZ TRANSMITTER TO NIHON KOHDEN. 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG WAVES ARE INTERMITTENTLY DROPPING FROM THE GZ TRANSMITTER AND AT THE REMOTE NURSE'S STATION (RNS) SO THE BIOMED SWAPPED IT OUT WITH ANOTHER GZ TRANSMITTER ON THE PATIENT, NO PATIENT HARM WAS REPORTED. BIOMED REPORTED THEY RAN THE DEVICE ON A SIMULATOR AND IT STILL CONTINUED TO DROP ECG WAVES. NO PHYSICAL DAMAGE TO THE UNIT REPORTED. BIOMED REQUESTED A WARRANTY EXCHANGE UNIT AND WILL RETURN THIS GZ TRANSMITTER TO NIHON KOHDEN.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG WAVES ARE INTERMITTENTLY DROPPING FROM THE GZ TRANSMITTER AND AT THE REMOTE NURSE'S STATION (RNS) SO THE BIOMED SWAPPED IT OUT WITH ANOTHER GZ TRANSMITTER ON THE PATIENT, NO PATIENT HARM WAS REPORTED. BIOMED REPORTED THEY RAN THE DEVICE ON A SIMULATOR AND IT STILL CONTINUED TO DROP ECG WAVES. NO PHYSICAL DAMAGE TO THE UNIT REPORTED. BIOMED REQUESTED A WARRANTY EXCHANGE UNIT AND WILL RETURN THIS GZ TRANSMITTER TO NIHON KOHDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039003 GZ-130P TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-130P NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown RNS| RNS