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

Model Number ZM-531PA

Device Problems Signal Artifact/Noise (1036); Intermittent Communication Failure (4038)

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 transmitter would intermittently have artifact.They tried different leads and mulitple patient group (org) receiver cards, but the issue persisted.They swapped transmitters in the same area, and the artifact was gone.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 transmitter would intermittently have artifact.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter would intermittently have artifact.They tried different leads and mulitple patient group (org) receiver cards, but the issue persisted.They swapped transmitters in the same area, and the artifact was gone.No patient harm was reported.Investigation summary: we were unable to confirm the reported issue as the customer never shipped back their defective device.Three good faith efforts (gfes) were made to the customer to return the defective unit but the customer was unresponsive to all attempts.As such, a definitive root cause could not be determined.However, based on the available information, the most probable root cause for ecg artifacts could be caused by internal component failure of the main board.We have identified some known issues with ecg/artifact, which are listed below for your reference: fuzzy or inaccurate waveforms such as sawtooth patterns or square waves, and wave artifacts such as signal noise, lead placement, lead connection, and network interference can be caused by faulty lead placement or faulty leads.Lead issues resulting in the above-mentioned failure modes would be immediately recognizable by the user and addressed promptly.The user should ensure that all cable connections are secure and that the leads are not damaged or contaminated.Mishandling can damage the inner wires of the leads, which can prevent data from reaching the transmitter and transferring over to the bsm or cns.The buildup of residues on contact points could interfere with the stable flow of data or create a weak signal.A serial number review of the reported device does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.Attempt # 1: 12/18/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 12/26/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: 01/03/2024 emailed the bme for all items under the no information list.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.Org: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the transmitter would intermittently have artifact.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: 18486686
• MDR Text Key: 333094947
• Report Number: 8030229-2024-04039
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/26/2012
• 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.; ORG.; ORG.