MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number	ZM-521PA
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the transmitter was producing a noisy ecg signal while in patient use.No patient harm was reported.They wanted to know what part could possibly be causing the issue.Technical support (ts) explained that the only part that could contribute to the poor signal would be the ecg module.On 10/01/2024, the bme responded to the email that the issue was resolved by replacing the ecg module in the device.There were no error messages, not related to leads.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 field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 09/18/2024 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 09/23/2024 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 09/30/2024 emailed the bme for the information in the ni list above: the bme replied but did have the requested information.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter was producing a noisy ecg signal while in patient use.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the transmitter was producing a noisy ecg signal while in patient use.No patient harm was reported.They wanted to know what part could possibly be causing the issue.Technical support (ts) explained that the only part that could contribute to the poor signal would be the ecg module.On 10/01/2024, the bme responded to the email that the issue was resolved by replacing the ecg module in the device.There were no error messages, not related to leads.Investigation summary: we were unable to confirm the reported issue.A definitive root cause could not be determined.However, based on the available information, the most probable root cause was due to ecg module failure, either caused by wear and tear, aging (device was approximately eight years old), or blunt force to the unit.The bme confirmed the issue had been resolved by replacing the ecg module within their unit at their facility.This was most likely caused by operator setup.We have identified known noise issues that may be caused by the following but not limited to faulty lead placement or faulty leads.Improper connection of leads (leads not properly seated) and/or damaged or contaminated leads (dirt, dust, and/or cleaning residues) may contribute to ecg issues.Buildup of residues on contact points could interfere with the stable flow of data or create a weak signal that may appear as a flat line or as broken waveforms on the transmitter, bsm, or cns.Lead issues resulting in the above-mentioned failure modes would be immediately recognizable by the user and addressed promptly.Temporary electrostatic discharge of the battery may result in inaccurate waveforms.Users should always be careful to replace the battery cover before use.A serial number review of the reported device (zm-521pa, serial number: (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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 3: on (b)(6) 2024: emailed the bme for the information in the ni list above: the bme replied but did have the requested information.Additional information: b4: date of this report.G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h6: event problem and evaluation codes.H11: additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter was producing a noisy ecg signal while in patient use.No patient harm was reported.

• Brand Name: ZM-521PA
• Common Device Name: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• 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: 20404088
• Report Number: 8030229-2024-04476
• Device Sequence Number: 6480186
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: (01)04931921115084
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown