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

Model Number	GZ-120PA
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the telemetry transmitter is getting hot and depleting batteries quickly compared to other transmitters and feels "hot" to the touch.Nihon kohden technical support suggested that this may happen if the display settings are set too bright and the screen time out is set too long or the batteries are inserted incorrectly in the unit.The customer reported that the settings are the same as the others.They found it to be hot when they went to change the batteries.Also, signal loss would show on the central nurse's station (cns) when the it became hot.The nurse stated that they have not had issues after the reported event.No patient harm reported.Concomitant medical device: the following devices were being used in conjunction with the telemetry transmitter, but no serial number information was provided.Central nurse's station model: cns-6801a.Sn: ni.
Event or Problem Description
The nurse reported that the telemetry transmitter is getting hot and depleting batteries quickly compared to other transmitters and feels "hot" to the touch.They found it to be hot when they went to change the batteries.Also, signal loss would show on the central nurse's station (cns) when the it became hot.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the transmitter was getting hot and depleting batteries quickly compared to other transmitters and felt "hot" to the touch.Technical support (ts) suggested that this may happen if the display settings are set too bright and the screen time out is set for too long or the batteries are inserted incorrectly in the unit.The customer reported that the settings are the same as the others.They found it to be hot when they went to change the batteries.Also, signal loss would show at the central nurse's station (cns) when the unit became hot.No harm or injury was reported.Investigation summary: ts advised the customer to double-check that the batteries were inserted properly and compare the screen brightness and screen time out settings with other gzs.In a follow-up with the customer, they indicated that the issue had not recurred since the original event.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.A possible cause of the issue could be battery failure, a short in the battery, or the use of a battery stored in an inappropriate temperature.Improper battery insertion is also a potential cause of the issue.
Event or Problem Description
The nurse reported that the telemetry transmitter is getting hot and depleting batteries quickly compared to other transmitters and feels "hot" to the touch.They found it to be hot when they went to change the batteries.Also, signal loss would show on the central nurse's station (cns) when the it became hot.No patient harm reported.

• 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: 10434661
• Report Number: 8030229-2020-00468
• Device Sequence Number: 11309145
• 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): 02/10/2023
• Report Date (Section F): 08/20/2020

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: 07/22/2020
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS -6801A; CNS -6801A
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/20/2020