MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems No Device Output (1435); Output Problem (3005)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter (tele) was only reading lead 2.There was no error message when this happened.They tested the unit with a simulator, and it had the same results.It is unclear whether this happened when they connected the leads to take ecg and found that it was not working or whether it failed in the midst of monitoring patient vitals.The bme has been unresponsive to questions regarding the latter information.Therefore, this complaint is being reported.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 Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) was only reading lead 2.There was no error message when this happened.They tested the unit with a simulator, and it had the same results.It is unclear whether this happened when they connected the leads to take ecg and found that it was not working or whether it failed in the midst of monitoring patient vitals.The bme has been unresponsive to questions regarding the latter information.Therefore, this complaint is being reported.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter (tele) was only reading lead 2.There was no error message when this happened.They tested the unit with a simulator, and it had the same results.It is unclear whether this happened when they connected the leads to take ecg and found that it was not working or whether it failed in the midst of monitoring patient vitals.The bme has been unresponsive to questions regarding the latter information.Therefore, this complaint is being reported.No patient harm was reported.Investigation conclusion: nihon kohden received the complaint device on 09/20/2023.Nihon kohden repair center evaluated the unit on 01/04/2024 and duplicated the complaint.The unit was tested with new batteries and set to auto lead and would only show lead 1 on the cns.The unit was tested with a new center case and the unit still only showed one lead.The issue was found to be due to mainboard failure.A definitive root cause for the mainboard failure could not be determined but possible cause may include electrical damage due to improper battery usage or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number shows that the device is 6 years old and has no other complaints.Due to the age of the device, wear-and-tear may be a likely contributing factor to the component failure.Review of the customer's complaint history for this issue and device did not show any trend for manufacturing defect.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) was only reading lead 2.There was no error message when this happened.They tested the unit with a simulator, and it had the same results.It is unclear whether this happened when they connected the leads to take ecg and found that it was not working or whether it failed in the midst of monitoring patient vitals.The bme has been unresponsive to questions regarding the latter information.Therefore, this complaint is being reported.No patient harm was reported.

• Brand Name: ZM-531PA
• Type of Device: 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: 17890352
• MDR Text Key: 326073327
• Report Number: 8030229-2023-03816
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• 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