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

Model Number ZM-541PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 09/25/2023

Event Type  malfunction  

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 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.

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 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.

• Brand Name: ZM-541PA
• 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: 18004651
• MDR Text Key: 326564063
• Report Number: 8030229-2023-03819
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• 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: 01/11/2024

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2010
• 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