MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION EEG-1200A; NEUROFAX ELECTROENCEPHALOGRAPH

Model Number EEG-1200A

Device Problem Power Problem (3010)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their computer turning off unexpectedly during a surgical case.The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on.No harm or injury was reported.Nihon kohden continues to investigate the reported event.Additional model information: device available for evaluation: the following non-nkc device was used in conjunction with the eeg-1200a: model: a/dell-7050sff s/n: (b)(4).

Event Description

The customer reported that their computer turning off unexpectedly during a surgical case.The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on.

Manufacturer Narrative

Details of complaint: the customer reported that the computer was turning off unexpectedly during a surgical case.They were able to recover with minimal data loss and continue recording, but only after a technician went into the room to turn the recorder back on.No harm or injury was reported.Investigation summary: a root cause could not be determined from the logs provided.There can be several possible causes for a pc suddenly turning off.1) overheating: if the computer's internal components, such as the cpu or graphics card, get too hot, it can trigger a safety mechanism that shuts down the system to prevent damage.Overheating can be caused by insufficient cooling, blocked vents, a malfunctioning fan, or dried-up thermal paste between the cpu and its heatsink.2) power supply issues: a faulty or insufficient power supply unit (psu) may cause the computer to shut down abruptly.If the psu is unable to deliver enough power to the components, the system might turn off to protect itself.3) hardware failure: a malfunctioning hardware component, such as a faulty motherboard, ram module, or hard drive, can cause sudden shutdowns.These failures might be due to age, manufacturing defects, or physical damage.4) software or driver issues: faulty or incompatible software or drivers can cause system instability and unexpected shutdowns.This can occur after installing new software, updating drivers, or experiencing conflicts between different software components.5) electrical issues: problems with the electrical supply, such as power surges or fluctuations, can cause the computer to shut down abruptly.This can happen if the psu or other components are not adequately protected by surge protectors or uninterruptible power supplies (ups).6) virus or malware infections: some malicious software can cause system instability or trigger shutdowns.Running up-to-date antivirus and antimalware scans can help identify and remove any potential threats.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.A2 - a6 b6 b7 attempt #1 03/04/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/11/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/25/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional model information: d10: the following non-nkc device was used in conjunction with the eeg-1200a: model: a/dell-7050sff s/n: (b)(6).

Event Description

The customer reported that the computer was turning off unexpectedly during a surgical case.They were able to recover with minimal data loss and continue recording, but only after a technician went into the room to turn the recorder back on.

• Brand Name: EEG-1200A
• Type of Device: NEUROFAX ELECTROENCEPHALOGRAPH
• 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: 11572948
• MDR Text Key: 245979732
• Report Number: 8030229-2021-00174
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: A/DELL-7050SFF-W10; COMPUTER: A/DELL-7050SFF-W10