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

Model Number ZM-531PA

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the transmitter has intermittent signal loss.The bme tried another transmitter on the same receiver card and had no signal loss at all in the same room.No patient harm was reported.The bme returned the device to nihon kohden for evaluation.

Manufacturer Narrative

Reported complaint: the biomedical engineer (bme) reported that the transmitter has intermittent signal loss.The bme tried another transmitter on the same receiver card and had no signal loss at all in the same room.No patient harm was reported.The bme returned the device to nihon kohden for evaluation.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 has intermittent signal loss.The bme tried another transmitter on the same receiver card and had no signal loss at all in the same room.No patient harm was reported.The bme returned the device to nihon kohden for evaluation.

Manufacturer Narrative

Reported complaint: the biomedical engineer (bme) reported that the transmitter has intermittent signal loss.The bme tried another transmitter on the same receiver card and had no signal loss at all in the same room.No patient harm was reported.The bme returned the device to nihon kohden for evaluation.Biomedical engineer requested an exchange unit to be sent in place of this unit.Investigation summary: nihon kohdne repair centers investigation of the device, they tested the unit with new batteries and discovered the unit had intermittent signal loss, to confirm the reported issue.Additionally, they found internal physical damage to the case, signs of fluid intrusion found near the outer edges of the case and near the antenna.A definitive root cause cannot be determined, based on the available information of the condition of the device inside the case, the most probable cause was contributed to customer mishandling/abuse (physical damage and fluid intrusion).To resolve the issue, an exchange unit (zm-531pa, serial number: (b)(6)) was shipped to the customer.Device history: 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 information were made, but not provided: attempt # 1: 11/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 11/16/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 11/17/2023 emailed the customer via microsoft outlook for patient information: no reply was received.

• 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: 18166825
• MDR Text Key: 329094814
• Report Number: 8030229-2023-03873
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2023
• 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
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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