MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number	ZM-530PA
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter frequently lost ecg waveforms.It would flatline and not give any readings or error messages.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the transmitter frequently lost ecg waveforms.It would flatline and not give any readings or error messages.The bme replaced the cables and leads and adjusted the lead placement on the patient, but the issue persisted.They tested the device on a simulator, and it displayed a flatline.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.Attempt # 1: (b)(6) 2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the bme for all information in the ni list above: the bme responded but did not provide the requested information.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: not returned.Org: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: not returned.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the transmitter frequently lost ecg waveforms.It would flatline and not give any readings or error messages.The bme replaced the cables and leads and adjusted the lead placement on the patient, but the issue persisted.They tested the device on a simulator, and it displayed a flatline.No patient harm was reported.Investigation summary: we were unable to confirm the reported issue.A definitive root cause could not be determined.The unit was never returned to nihon kohden for proper evaluation of the reported issue.The most probable root cause of ecg dropping/flatlining could have been caused by unstable communication with telemetry unit and the cns or could have been caused by customer mishandling/damage to the unit.However, three gfes were sent to the customer to follow up on this reported issue, and the customer was unresponsive.We have identified known ecg related issues which include, device/module failure: failure of the module and/or its components can occur due to physical damage.Internal damage of the device may cause incomplete sending of data or prohibit the device from connecting to the network, the bsm, or the cns.Normal wear and tear dependent on the age of the device and the frequency of its use.A serial number review of the reported device (model: zm-540pa, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.
Event or Problem Description
The biomedical engineer (bme) reported that the transmitter frequently lost ecg waveforms.It would flatline and not give any readings or error messages.No patient harm was reported.

• Brand Name: ZM-530PA
• Common Device Name: 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: 19845324
• Report Number: 8030229-2024-04372
• Device Sequence Number: 6647876
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2013
• 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: CNS; CNS; ORG; ORG
• Patient Sex: Unknown