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

Model Number GZ-130PA

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz monitor goes in and out of communication loss intermittently and that it randomly will not pick up the leads/waveforms while in use on a patient, no patient injury occurred.Nihon kohden technical support sent a warranty exchange unit to the customer and provided the customer with a return authorization number to return their unit to nk.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.Attempt # 1: 08/31/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/01/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 09/07/2022 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The biomedical engineer reported that the gz monitor goes in and out of communication loss intermittently and that it randomly will not pick up the leads/waveforms while in use on a patient, no patient injury occurred.Nihon kohden technical support sent a warranty exchange unit to the customer and provided the customer with a return authorization number to return their unit to nk.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the gz monitor goes in and out of communication loss intermittently and that it randomly will not pick up the leads/waveforms while in use on a patient, no patient injury occurred.Nihon kohden technical support sent a warranty exchange unit to the customer and provided the customer with a return authorization number to return their unit to nk.Investigation summary: review of serial number history shows no previous related issues with device reported.Communication loss is an error message displayed on individual bed tiles on the cns that alerts clinicians that the connection between the cns and the device it is monitoring has been lost.

Event Description

The biomedical engineer reported that the gz monitor goes in and out of communication loss intermittently and that it randomly will not pick up the leads/waveforms while in use on a patient, no patient injury occurred.Nihon kohden technical support sent a warranty exchange unit to the customer and provided the customer with a return authorization number to return their unit to nk.

• 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 ; 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: 15374263
• MDR Text Key: 305830156
• Report Number: 8030229-2022-03054
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2021
• 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