BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORG-9110A

    MDR report key: 10289807 · Received July 17, 2020

    Report

    Report Number
    8030229-2020-00393
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    June 16, 2022
    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) STARTED DISPLAYING SIGNAL LOSS FOR 4 TRANSMITTERS. THEY SENT THE UNIT IN FOR EVALUATION AND REPAIR. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: EVALUATION / REPAIR. INVESTIGATION SUMMARY: NIHON KOHDEN REPAIR CENTER (NK RC) WAS NOT ABLE TO DUPLICATE THE ISSUE OF COMMUNICATION LOSS. THE ORG WAS EXCHANGED IN TICKET 102933 TO RESOLVE THE ISSUE. 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, THE ISSUE OF SIGNAL LOSS IS UNLIKELY RELATED TO A DESIGN OR MANUFACTURING DEFICIENCY OF AN NK DEVICE. A CAPA IS NOT WARRANTED. ADDITIONAL DEVICE INFORMATION: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI. TELEMETRY TRANSMITTERS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) STARTED DISPLAYING SIGNAL LOSS FOR 4 TRANSMITTERS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) STARTED DISPLAYING SIGNAL LOSS FOR 4 TRANSMITTERS. NO HARM OR INJURY WAS REPORTED. THEY WILL BE SENDING THIS ORG IN FOR A REPAIR. 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 CNS, AND ARE NOT THE DEVICES THAT EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: BSM - 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 THE MULTIPLE PATIENT RECEIVER (ORG) STARTED DISPLAYING SIGNAL LOSS FOR 4 TRANSMITTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755516 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| CNS