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

Model Number GZ-130PA

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter (tele) was showing artifact and was getting inaccurate heart rhythms.They have changed the leads and cables, but the issue persists.No patient harm was 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 are not applicable (na) to the mdr report: b2.D4 lot number & expiration.D6a - d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D10 concomitant medical device.Attempt #1.11/17/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2.11/29/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3.12/11/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station.Model: ni.Sn: ni.

Event Description

The biomedical engineer reported that the telemetry transmitter (tele) was showing artifact and was getting inaccurate heart rhythms.They have changed the leads and cables, but the issue persists.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was showing artifact and was getting inaccurate heart rhythms.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was showing artifact and was getting inaccurate heart rhythms.They changed the leads and cables, but the issue persisted.No patient harm was reported.Investigation summary: nihon kohden (nk) was unable to confirm the reported issue as the device was never returned to nk for evaluation.The bme that originally reported the issue no longer works at the facility.Their clinical engineer confirmed that at the time, the bme ran a functional verification test after replacing the leads, which was run on a simulator.The bme confirmed with the war room that the unit was working as intended, (no malfunctions) and was placed back into service after testing.As such, a definitive root cause could not be determined.But based on the available information, the most probable root cause could be contributed to defective leads or incorrect lead placement.Another possible cause for egc issues could be that the user turned off the display settings for respiratory or heart rate.The displayed numeric values of hr and rr may differ between a transmitter and a receiving monitor because of detection settings on both devices.Lead placement and connections, user education, the heart rate calculation method used (depending on p wave/grs), movement in the chest and abdomen may influence measurements.Additionally, amplitude varies depending on placement of the electrodes and can cause differing heart rate measurements between the transmitter, bsm, and cns.Leads may need to be adjusted at the bedside monitor or transmitter.A serial number review of the reported device (gz-130pa, sn (b)(6)) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.

• 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: 18326975
• MDR Text Key: 330501805
• Report Number: 8030229-2023-03908
• 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: 03/07/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2018
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION