MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

The customer reported that the spo2 is not displaying waves or numeric.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the spo2 is not displaying waves or numeric.According to the customer, the cable will not light up so it isn't being recognized.The customer tried multiple cables; however, the issue persisted.The customer is sending in the unit to be exchanged.There was no patient injury 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.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: concomitant medical products: the following device was used in conjunction with the transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: no.

Event Description

The customer reported that the spo2 is not displaying waves or numeric.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the spo2 is not displaying waves or numeric.According to the customer, the cable will not light up so it isn't being recognized.The customer tried multiple cables; however, the issue persisted.The customer is sending in the unit to be exchanged.There was no patient injury reported.Investigation summary: the nk repair center received the complaint device and duplicated the complaint issue.The nk repair center found that the cd-334p sensor unit had an electronic failure.A definitive cause for this issue could not be determined.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 04/11/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 04/17/2023 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 transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: no additional information: b4 date of this report d9 device available for evaluation g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer h10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.

• Brand Name: GZ-130PA
• 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: 16773631
• MDR Text Key: 313942236
• Report Number: 8030229-2023-03475
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• 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: 07/14/2023

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-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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