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

Model Number	ZM-530PA
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this unit is not reading the ecg.The customer will send in the unit to be exchanged.There was no patient injury 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.D10 attempt # 1: 10/07/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; the telemetry was connected to asset model name : cns 6801-32 and serial number : (b)(6).Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the transmitter: cns: model #: pu-681ra.Serial #: (b)(6).Device manufacturer date: 05/12/2022.Unique identifier (b)(4).Returned to nihon kohden: no.
Event or Problem Description
The customer reported that this unit is not reading the ecg.There was no patient injury reported.
Event or Problem Description
The customer reported that this unit is not reading the ecg.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this unit is not reading the ecg.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: the returned unit was evaluated and the complaint was duplicated.The cause of the issue was circuit board failure.D10 attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; the telemetry was connected to asset model name : cns 6801-32 and serial number : (b)(6).Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the transmitter: cns: model #: pu-681ra, serial #: (b)(6), device manufacturer date: 05/12/2022, unique identifier (b)(4), returned to nihon kohden: no.

• 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: 20506138
• Report Number: 8030229-2024-04480
• Device Sequence Number: 8209904
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: (01)04931921115091
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/25/2025

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2012
• 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.
• Patient Sex: Unknown