MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the hr is fluctuating up and down when using this device.This issue remains even when using different leads and on a simulator.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.
Event or Problem Description
The biomedical engineer (bme) reported that the hr is fluctuating up and down when using this device.This issue remains even when using different leads and on a simulator.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the hr is fluctuating up and down when using this device.This issue remains even when using different leads and on a simulator.No patient harm was reported.Investigation conclusion: follow-up e-mails were sent to the customer on 12/29/2023 and 01/02/2024 to see if further assistance was needed or if there was any resolution.The customer replied on 01/03/2024 that they replaced the main board.A definitive root cause for this issue could not be determined since the device would not be returned for evaluation.The cause of the issue was most likely hardware component failure of the main board.This can occur due to physical damage or fluid intrusion from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number does not show recurrence or other complaints.The complaint device is 12 years old.Due to the age of the device, wear-and-tear may be a likely contributing factor to hardware component failure.Review of the customer's complaint history does not show other similar complaints.The following fields are not applicable (na) to the mdr report: the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device.Attempt #1 09/26/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 10/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the hr is fluctuating up and down when using this device.This issue remains even when using different leads and on a simulator.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the hr is fluctuating up and down when using this device.This issue remains even when using different leads and on a simulator.No patient harm was reported.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a, per the fda request.

• Brand Name: ZM-541PA
• 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: 18004651
• Report Number: 8030229-2023-03819
• Device Sequence Number: 12671984
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: (01)04931921106617(21)219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 07/24/2024

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-541PA
• Device Catalogue Number: ZM-541PA
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 01/10/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/11/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2010
• 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
• Patient Sex: Unknown