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

Model Number ZM-531PA

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.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 zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.

Manufacturer Narrative

Complaint report: the biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.Investigation summary: the reported issue was duplicated and confirmed.Upon evaluation from the repair center, the unit was tested with new batteries, connected to a simulator and the device displayed artifacts and intermittent signal loss.Repair center stated the main board was defective and the device would be scrapped.This unit has expired the warranty period.A serial number review of the reported device (zm-531pa, 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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/18/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/02/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/08/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.G3 date received by manufacturer on initial medwatch, date that initial report was received by manufacturer was 8-jan-2024.

Event Description

The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.The bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.

Manufacturer Narrative

Complaint report: the biomedical engineer (bme) reported that the zm transmitter was getting a lot of intermittent artifact for electrocardiography (ecg) while in patient use.Bme reports that he tried other receiver cards but it still gets the artifact, when swapping the telemetry in the same area the artifact goes away.Bme requested an exchange and will return this unit to nihon kohden.No patient harm was reported.Investigation summary: the reported issue was duplicated and confirmed.Upon evaluation from the repair center, the unit was tested with new batteries, connected to a simulator and the device displayed artifacts and intermittent signal loss.Repair center stated the main board was defective and the device would be scrapped.This unit has expired the warranty period.A serial number review of the reported device (zm-531pa, 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.Additional information: b4 date of this report.G3 date received by manufacturer.G3 date received by manufacturer on initial medwatch, date that initial report was received by manufacturer was 8-jan-2024.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.

• 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: 18472116
• MDR Text Key: 332744760
• Report Number: 8030229-2024-03986
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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