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

Model Number GZ-140PA

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 315086718
• Report Number: 8030229-2023-03502
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS