BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORG-9110A

    MDR report key: 10219651 · Received July 1, 2020

    Report

    Report Number
    8030229-2020-00349
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 9, 2020
    Report Date
    March 3, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRG
    UDI-DI
    04931921103906
    PMA / PMN Number
    K071058
    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

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GIVING AN INTERMITTENT "COMM LOSS" ERROR FOR FOUR TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) HAD RECEIVED THE UNIT IN QUESTION TWICE IN TICKETS 84092 AND 92716 WHERE THEY WERE NOT ABLE TO DUPLICATE THE ISSUE OF COMM LOSS. THE ORG WAS LATER EXCHANGED IN TICKET 102933. THE ROOT CAUSE FOR THIS ISSUE IS LIKELY RELATED TO ENVIRONMENTAL FACTORS COMBINED WITH NORMAL WEAR AND TEAR DUE TO THE AGE OF THE DEVICE. IT WAS INSTALLED AT THE CUSTOMER'S FACILITY IN 06/2010. AS THE DEVICE WAS EVALUATED AND FOUND TO BE IN GOOD WORKING ORDER IN BOTH TICKETS 84092 AND 92716, THE ISSUE OF COMM LOSS IS UNLIKELY RELATED TO A DESIGN OR MANUFACTURING DEFICIENCY OF AN NK DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GIVING AN INTERMITTENT "COMM LOSS" ERROR FOR FOUR TELEMETRY TRANSMITTERS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY ARE RECEIVED AND INTERMITTENT "COMMUNICATION LOSS" ERROR FOR ONE MULTIPLE PATIENT RECEIVER (ORG) (TOTAL OF 4 TRANSMITTERS). NO PATIENT HARM OR INJURY 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. ADDITIONAL MODEL INFORMATION: 4 TRANSMITTERS WERE USED IN CONJUNCTION WITH THE ORG, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: TRANSMITTERS: MODEL: NI, S/N: NI. APPROXIMATE AGE OF THE DEVICE: NI. NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ARE RECEIVED AND INTERMITTENT "COMMUNICATION LOSS" ERROR FOR ONE MULTIPLE PATIENT RECEIVER (ORG) (TOTAL OF 4 TRANSMITTERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682766 ORG-9110A MULTIPLE PATIENT RECEIVER DRG NIHON KOHDEN CORPORATION ORG-9110A NA 04931921103906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 4 TRANSMITTERS| 4 TRANSMITTERS