MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-140PA; TRANSMITTER

Model Number	GZ-140PA
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the spo2 was set on the simulator to 80%, but the readings on the gz transmitter were near 85% which is out of range.The customer asked if the spo2 could be calibrated, but technical support (ts) informed the customer that this is not possible.The customer will do one more test and if the issue remains, the unit will be exchanged.The unit was not in patient use at the time.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 fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023, emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.
Event or Problem Description
The customer reported that the spo2 was set on the simulator to 80%, but the readings on the gz transmitter were near 85% which is out of range.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the spo2 was set on the simulator to 80%, but the readings on the gz transmitter were near 85% which is out of range.The customer asked if the spo2 could be calibrated, but technical support (ts) informed the customer that this is not possible.The customer will do one more test and if the issue remains, the unit will be exchanged.The unit was not in patient use at the time.Investigation summary: customer reported that during their preventative maintenance the device did not pass the spo2 accuracy test.On a follow-up from the customer, customer indicated that when they re-tested the device, the device was functioning within manufacturing specifications.Manufacturer refereces # (b)(4) follow up 001.
Event or Problem Description
The customer reported that the spo2 was set on the simulator to 80%, but the readings on the gz transmitter were near 85% which is out of range.There was no patient injury reported.

• Brand Name: GZ-140PA
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16916735
• Report Number: 8030229-2023-03502
• Device Sequence Number: 17870206
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K163459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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-140PA
• Device Catalogue Number: GZ-140PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS; CNS
• Patient Sex: Unknown