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	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse manager reported that the transmitter was having a higher than usual temperature.The patient complained that it was hot.They took it out of service and had a ce run a series of tests on it.None of the tests were conclusive.Nihon kohden technical support believes that the highest temp they reached was around 100 degrees f.No patient harm reported.The customer later communicated to nk that they believe that this was an isolated and patient specific issue.Upon assessing, the pack was not "hot" enough to cause burns, no burns were noted on patient exam and the pack was warm to the touch (as most battery operated items get when used for a prolonged period of time).Nk's clinical engineering team was not able to recreate this nor has nk noticed this in any other pack.Nk did not want to send it to quality assurance it was felt it was a subjective complaint from the patient that was not necessarily factual.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 device information: 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 nurse manager reported that the transmitter was having a higher than usual temperature.The patient complained that it was hot.They took it out of service and had a ce run a series of tests on it.None of the tests were conclusive.Nihon kohden technical support believes that the highest temp they reached was around 100 degrees f.No patient harm reported.The customer later communicated to nk that they believe that this was an isolated and patient specific issue.Upon assessing, the pack was not "hot" enough to cause burns, no burns were noted on patient exam and the pack was warm to the touch (as most battery operated items get when used for a prolonged period of time).Nk's clinical engineering team was not able to recreate this nor has nk noticed this in any other pack.Nk did not want to send it to quality assurance it was felt it was a subjective complaint from the patient that was not necessarily factual.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the patient complained that the gz transmitter became "warm" during use.The customer was not able to recreate/duplicate this issue with the complaint device.On a follow up with the customer, they indicated that this might have been an isolated case.They indicated that the device was not hot enough to cause burns on the patient as the patient did not have any burns during the exam.The customer suspected that this may be similar to most battery-operated devices that warms up after using for a prolonged period of time.No harm or injury was reported.Investigation summary: 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.As the customer was unable to observe or recreate the issue, the reported defect could not be confirmed.Possible cause of the issue is battery failure, short in battery, or use of a battery stored in an inappropriate temperature.
Event or Problem Description
The nurse manager reported that the transmitter was having a higher than usual temperature.The patient complained that it was hot.They took it out of service and had a ce run a series of tests on it.None of the tests were conclusive.Nihon kohden technical support believes that the highest temp they reached was around 100 degrees f.No patient harm reported.The customer later communicated to nk that they believe that this was an isolated and patient specific issue.Upon assessing, the pack was not "hot" enough to cause burns, no burns were noted on patient exam and the pack was warm to the touch (as most battery operated items get when used for a prolonged period of time).Nk's clinical engineering team was not able to recreate this nor has nk noticed this in any other pack.Nk did not want to send it to quality assurance it was felt it was a subjective complaint from the patient that was not necessarily factual.

• 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: 9857818
• Report Number: 8030229-2020-00165
• Device Sequence Number: 2663923
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023
• Report Date (Section F): 03/19/2020

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: 02/26/2020
• Device Age: 36 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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 SN (B)(6) ; CNS-6801A SN (B)(6)
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/19/2020