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

Model Number ZM-531PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter would randomly power off with new batteries.There were no signs of physical damage or fluid intrusion.No information will be provided regarding patient use or model information of the cns the device was being monitored on at the time.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 customer reported that the transmitter would randomly power off with new batteries.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter would randomly power off with new batteries.There were no signs of physical damage or fluid intrusion.No information will be provided regarding patient use or the model information of the cns the transmitter was being monitored on at the time.Investigation summary: the transmitter was sent in for an exchange.During the evaluation of the returned device nihon kohden repair center (nk rc) observed fluid intrusion inside the unit.Fluid intrusion is likely to result in hardware damage which may have caused the unit to shut down unexpectedly.The root cause is related to user mishandling as the zm transmitter is not a waterproof device.Fluids can damage electronics through various mechanisms, and the extent of damage depends on the type of fluid, the duration of exposure, and the specific electronic components involved.Some ways in which fluids can harm electronics: conductivity: many fluids, especially water and other aqueous solutions, are conductive.When these fluids come into contact with electronic components, they can create unintended electrical pathways, causing short circuits.Short circuits can lead to the overheating and failure of electronic devices.Corrosion: fluids, especially those containing salts or other corrosive substances, can corrode metal components on circuit boards.Corrosion can degrade the functionality of the components, reduce electrical conductivity, and cause long-term damage.Oxidation: exposure to moisture can lead to oxidation of metal parts on electronic circuits.Oxidation can weaken connections and reduce the overall performance of electronic devices.Damage to insulation: some fluids can compromise the insulation on wires and other components.This can lead to leakage currents, shorts, and other electrical issues.Capillary action: fluids can be drawn into small spaces through capillary action, reaching components that may not be immediately visible.This can lead to hidden damage that may not be immediately apparent.Chemical reactions: the chemical composition of some fluids can react with the materials used in electronic components.Such chemical reactions can lead to changes in the properties of these materials, potentially resulting in malfunctions or failures.Drying issues: even if the electronic device appears to work after being exposed to a liquid, there can be residual moisture trapped in hard-to-reach places.This lingering moisture can cause problems over time, such as corrosion or gradual degradation of electronic components.

Event Description

The customer reported that the transmitter would randomly power off with new batteries.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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15874175
• MDR Text Key: 307685749
• Report Number: 8030229-2022-03220
• 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: 10/10/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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