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

Model Number GZ-130PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Patient Data Problem (3197)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter will randomly show flat line for all ecg waves.The bme tried different cables and ran the unit on a simulator and has reproduced the issue.There are no waves on the unit itself.No patient harm was reported.No physical damage to the device.Biomed requested a warranty exchange on the device and will return this unit.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.

Event Description

The biomedical engineer (bme) reported that the gz transmitter will randomly show flat line for all ecg waves.The bme tried different cables and ran the unit on a simulator and has reproduced the issue.There are no waves on the unit itself.No patient harm was reported.No physical damage to the device.Biomed requested a warranty exchange on the device and will return this unit.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the ecg readings on the gz transmitter would intermittently flatline.The bme ran the device on a simulator after changing the cables, but the issue persisted.No patient harm was reported.Investigation summary: the reported device was sent in for repair and evaluation.Nihon kohden repair center (nk rc).Nk rc found that although the device was currently dry, it had been exposed to moisture at some point.A sticky residue was noticeable on the ecg socket located on the front case.Additionally, the battery cover was missing.The device was tested per the gz-130pa operator's manual, undergoing 24-hours of testing and it was found to be functioning according to the manufacturer's specifications.The reported issue was not duplicated or confirmed.Based on the findings from repair center, the reported issue of the device having had issues with ecg waveforms and flatlining could be contributed to the fluid intrusion that the unit was exposed to.To resolve the issue a brand-new exchange unit (gz-130pa, sn: 06335) was successfully shipped to the customer.A serial number review of the reported device (model: gz-130pa, sn: 4477) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Attempt # 1: 01/10/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/18/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/24/2024 emailed the customer via microsoft outlook for all information in the ni list above:no reply was received.

Event Description

The biomedical engineer (bme) reported that the ecg readings on the gz transmitter would intermittently flatline.The bme ran the device on a simulator after changing the cables, but the issue persisted.No patient harm was reported.

• 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: 18577001
• MDR Text Key: 334731785
• Report Number: 8030229-2024-04055
• 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: 05/20/2024

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: 01/02/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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