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

Model Number GZ-130PA

Device Problem Output Problem (3005)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

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 customer reported that one of their patients was having runs of vt-triplets (4 bts vt), but the nk system was registering them as pauses.The leads had been changed from lead 2 to lead 1, but they keep falling off when switched in full disclosure.No harm or injury was reported.

Event Description

The customer reported that one of the patients was having runs of vt-triplets (4 bts vt), but the gz transmitter was registering them as pauses.Changing the leads from lead 2 to lead 1 did not resolve the issue.No harm or injury was reported.

Manufacturer Narrative

Details of complaint: the customer reported that one of the patients was having runs of vt-triplets (4 bts vt), but the gz transmitter was registering them as pauses.Changing the leads from lead 2 to lead 1 did not resolve the issue.No harm or injury was reported.Investigation summary: the device log files were sent in for analysis and investigation.The analysis of the waveforms found that the amplitude of the vpc was too small to be recognized as a qrs, resulting in a pause alarm instead of a run.Nkc analyzed the waveforms on the given pictures and found the amplitude of the waveform that seems to be vpc was small.Also, nkc confirmed many "cannot analyze" log messages in the files.The waveform that seemed to be vt was not judged as a "v" beat because the amplitude of vpc was small and could not be recognized as qrs in the arrythmia algorithm.Although the normal beat had a small amplitude, it was recognized as a qrs complex, but the vpc had the same amplitude as the normal beat and the qrs width was wide.Due to its wide size, it could not be recognized as a qrs.Therefore, the arrhythmia alarm of "pause" which means the resting state of the heartbeat and the technical alarm of "cannot analyze" which means the state where the analysis cannot be performed were generated.It was recommended that the customer review patient prep procedures to obtain larger rs amplitudes.There is no evidence of a device malfunction.The device logs and waveforms were analyzed, and no issue was found with the devices involved.The root cause is related to patient prep.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13079937
• MDR Text Key: 284989730
• Report Number: 8030229-2021-02143
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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