MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the zm transmitter was showing artifact/noises within the wavefroms while in patient use.No patient harm was reported.Nihon kohden technical support had the bme un-monitor and re- monitor the device and the bme reported the waveform becomes intermittent afterwards, that it would have no artifacts at first then within 1 minute it starts having artifacts.Nk technical support had the bme turn on the hum filter within the cns but when the bme did the problem still persisted.Nk technical support had the bme change the zm with new cables and clean the connector on the zm itself but the issue is still persisting.Nk technical support had the bme change the zm transmitter with a spare unit and the waveforms were no longer having artifacts.Bme requested to send their zm transmitter into nihon kohden for repair.

Manufacturer Narrative

The biomedical engineer (bme) reported that the zm transmitter was showing artifact/noises within the wavefroms while in patient use.No patient harm was reported.Nihon kohden technical support had the bme un-monitor and re- monitor the device and the bme reported the waveform becomes intermittent afterwards, that it would have no artifacts at first then within 1 minute it starts having artifacts.Nk technical support had the bme turn on the hum filter within the cns but when the bme did the problem still persisted.Nk technical support had the bme change the zm with new cables and clean the connector on the zm itself but the issue is still persisting.Nk technical support had the bme change the zm transmitter with a spare unit and the waveforms were no longer having artifacts.Bme requested to send their zm transmitter into nihon kohden for repair.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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.

Manufacturer Narrative

Incident summary: the biomedical engineer (bme) reported that the zm transmitter was showing artifact/noises within the wavefroms while in patient use.No patient harm was reported.Nihon kohden technical support had the bme un-monitor and re- monitor the device and the bme reported the waveform becomes intermittent afterwards, that it would have no artifacts at first then within 1 minute it starts having artifacts.Nk technical support had the bme turn on the hum filter within the cns but when the bme did the problem still persisted.Nk technical support had the bme change the zm with new cables and clean the connector on the zm itself but the issue is still persisting.Nk technical support had the bme change the zm transmitter with a spare unit and the waveforms were no longer having artifacts.Bme requested to send their zm transmitter into nihon kohden for repair.Device received to nihon kohden repair center and was tested for the reported problem: "zm-520 showing noises with the waveform", which was duplicated when tested when connected to a cns found intermittent signal loss and noise in the waveforms.Physical inspection found the rear case was damaged and signs of fluid intrusion in the unit.This unit was scrapped and an exchange unit was shipped to the customer.Investigation results: the reported issue was duplicated and confirmed.Upon evaluation from repair center, they connected the unit to the cns for monitoring.They found the unit to have signal loss, internal rear case damage and signs of fluid intrusion were found within the unit.A definitive root cause could not be determined.But based on the findings from repair center the most probable root cause could be due to customer mishandling (physical damage and fluid intrusion).To resolve the issue an exchange unit (zm-520pa, serial number: (b)(6) was shipped to the customer.A serial number review of the reported device (model: zm-520pa, 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 manufacturer: b4 date of this report g3 date received by manufacturer g6 type of report h2 if followup, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the zm transmitter was showing artifact/noises within the wavefroms while in patient use.No patient harm was reported.Nihon kohden technical support had the bme un-monitor and re- monitor the device and the bme reported the waveform becomes intermittent afterwards, that it would have no artifacts at first then within 1 minute it starts having artifacts.Nk technical support had the bme turn on the hum filter within the cns but when the bme did the problem still persisted.Nk technical support had the bme change the zm with new cables and clean the connector on the zm itself but the issue is still persisting.Nk technical support had the bme change the zm transmitter with a spare unit and the waveforms were no longer having artifacts.Bme requested to send their zm transmitter into nihon kohden for repair.

• Brand Name: ZM-520PA
• 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: 18636926
• MDR Text Key: 334787949
• Report Number: 8030229-2024-04080
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2018
• 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
• Treatment: CNS; CNS