BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORG-9100A

    MDR report key: 22075556 · Received May 22, 2025

    Report

    Report Number
    8030229-2025-04938
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 23, 2025
    Report Date
    August 18, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRG
    UDI-DI
    04931921103883
    PMA / PMN Number
    K071058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6). 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 FIELD CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 04/28/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/12/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 05/16/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED WITH THE CNS INFORMATION BUT DID NOT HAVE THE TRANSMITTERS' INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #:PU-681RA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 02/15/2021 (FEB. 15, 2021) UNIQUE IDENTIFIER (UDI) #: (B)(4). ZM TRANSMITTERS: MODEL #:NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6)) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6)). NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: SPORADIC ECG READINGS (FLUCTUATING BETWEEN 90-120 BPM) ON TELE 8, DESPITE STABLE READINGS ON THE SIMULATOR. NK TECH SUPPORT ADVISED TESTING A DIFFERENT TELEMETRY UNIT WITH THE SAME RECEIVER, WHICH CONFIRMED THE ISSUE WAS WITH THE RECEIVER. THE BIOMED REPLACED THE RECEIVER CARD IN THE ORG, RESOLVING THE PROBLEM. THE CNS INVOLVED WAS A PU-681RA (SN: (B)(6)). THE ISSUE RESOLVED WHEN THE CUSTOMER REPLACED THE RECEIVER CARDS IN THE ORG. ROOT CAUSE DETERMINED TO BE COMPONENT FAILURE OF THE ORG RECEIVER CARD DUE TO AGING. THE DEVICE WAS INSTALLED ON (B)(6) 2008. THE ROOT CAUSE IS LIKELY RELATED TO DEVICE AGING. THE FOLLOWING FIELD CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 04/28/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/12/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 05/16/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED WITH THE CNS INFORMATION BUT DID NOT HAVE THE TRANSMITTERS' INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG:. CNS:. MODEL #:PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 02/15/2021 (FEB. 15, 2021). UNIQUE IDENTIFIER (UDI) #: (B)(4). ZM TRANSMITTERS: MODEL #:NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6). NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6)) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6)). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972176 ORG-9100A MULTIPLE PATIENT RECEIVER DRG NIHON KOHDEN CORPORATION ORG-9100A NA 04931921103883

    Patients

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