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

Model Number ZM-531PA

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The customer reported intermittent problems with this transmitter.The unit was not in patient use at the time.

Manufacturer Narrative

The customer reported intermittent problems with this transmitter.According to the customer, they have to "fiddle around" to get readings and sometimes the unit does not produce readings at all.The customer will send in the unit to be repaired.The unit was not in patient use at the time.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 information were made, but not provided: a2 - a6.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.D10 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.

Manufacturer Narrative

Details of complaint: the customer reported intermittent problems with this transmitter.According to the customer, they have to "fiddle around" to get readings and sometimes the unit does not produce readings at all.The customer will send in the unit to be repaired.The unit was not in patient use at the time.Investigation summary: the reported issue of intermittent or no readings on the device could not duplicated during evaluation of the returned device.The insulation sheet was found to not be attached properly and residue was found on the device.There were no signs of fluid intrusion found.Environmental factors are most likely related to the reported issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.B6 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.B7 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.D10 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the requested information will not be provided.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.Manufacturer references # (b)(4).

Event Description

The customer reported intermittent problems with this transmitter.The unit was not in patient use at the time.

• 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: 18522995
• MDR Text Key: 333322728
• Report Number: 8030229-2024-04014
• 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: 03/26/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CNS.; CNS.