MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number	GZ-120PA
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.They were not sure if a staff member manually discharged the patient.Nk ts asked that they provide the cns logs in order to perform an investigation, however nk has not yet received the logs.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 contains no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.
Event or Problem Description
The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.
Event or Problem Description
The biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer reported that the gz transmitter discharged the patient, possibly without user intervention.They were not sure if a staff member manually discharged the patient.No patient harm or injury was reported.Investigation summary: the customer stated they were unsure if the patient was discharged on the remote network station (rns) as well as the central nurse's station (cns).Nihon kohden technical support (nk ts) requested event logs, and the customer stated they would call back if it happened again.Follow-up correspondence for information did not receive a reply.With the information available it is reasonable to determine the root cause to be man (user education).A review of the serial number history shows no recurrence of the reported event.Admitting patients and inputting their patient information can be done on the transmitter as long as the previous patient has been discharged through the "discharging a patient" section.

• Brand Name: GZ-120PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10440388
• Report Number: 8030229-2020-00461
• Device Sequence Number: 2949164
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023
• Report Date (Section F): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2020
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/21/2020