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

Model Number	GZ-120PA
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.No patient harm 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.Concomitant medical device: the following devices were being used in conjunction with the telemetry transmitter: central nurse's station, model: cns-6801a, sn: (b)(4).
Event or Problem Description
The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that a gz-120pa transmitter had a patient name disappear from the cns tile, however, the vitals were still present.The cns was monitoring a gz transmitter and when the nurse re-entered the id, the patient showed up again.Service requested / performed: troubleshooting.Investigation summary: if the reported malfunction were to recur and the patient's name and patient id disappeared from the tile, it could cause confusion and delay of patient treatment in the case of an event.The reported event would be likely to cause or contribute to death or serious injury if a patient event were missed.The root cause of this issue cannot be determined as there was not enough information provided from the customer.Attempts to obtain further information were made, however, the customer was unresponsive.The overall risk rating is medium.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: central nurse's station: model #: cns-6801a; serial #: (b)(6); device manufacturer data: dd/mm/yyyy; unique identifier (udi) #: (b)(4); returned to nihon kohden: dd/mm/yyyy.
Event or Problem Description
The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.No patient harm reported.

• Brand Name: GZ-120PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• MDR Report Key: 10463383
• Report Number: 8030229-2020-00475
• Device Sequence Number: 14271280
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021
• Report Date (Section F): 08/27/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2020
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6801A SN (B)(6).; CNS-6801A SN (B)(6).
• Date Report Sent to FDA: 08/27/2020