MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

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

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.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: 02/14/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from the biomedical engineer who stated he was unable to document patient information.He did not provide the model number or serial number of the cns in the concomitant medical device in section d10.

Event Description

The biomedical engineer (bme) reported that the zm transmitter was showing artifacts on heart rhythms while in patient use.The bme removed and replaced this transmitter being use with the patient.No patient harm was reported.The bme reported that after they replaced this device, he tested the device on their monitor and alone on a simulator.The device would show artifact on the display.The telemetry monitor displays and sends incorrectly nothing to the cns.Bme requested to send the device into nihon kohden for a warranty exchange unit.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 18852644
• MDR Text Key: 337676913
• Report Number: 8030229-2024-04167
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2013
• 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