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

Model Number	EEG-1200A
Medical Device Problem Codes	Application Program Problem (2880); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eeg reported that the patient name on the (b)(6) study had changed.They had started the study and when they finished recording there was a different patient name.It is unclear if someone accidentally changed the name or not.They are not sure how this happened.Nihon kohden technical support (tech support) assisted in changing the patient information.No patient harm 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 or Problem Description
The eeg reported that the patient name on the (b)(6) study had changed.They had started the study and when they finished recording there was a different patient name.It is unclear if someone accidentally changed the name or not.They are not sure how this happened.Nihon kohden technical support (tech support) assisted in changing the patient information.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the eeg technician reported that the patient's name on the ltm study had changed.It is unclear if someone accidentally changed the name or not.Nihon kohden technical support (nk ts) assisted in changing the patient information.No harm or injury was reported.Investigation summary: the allegation of the patient's name changing on its own could not be confirmed.It is more common that the user selected the incorrect name at the start of the exam.Patient information issues are easily resolved by editing the information for the files in question.There have been no additional complaints reporting of automatic patient name changes after recording.The root cause is likely use error.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.
Event or Problem Description
The eeg reported that the patient name on the ltm study had changed.They had started the study and when they finished recording there was a different patient name.It is unclear if someone accidentally changed the name or not.They are not sure how this happened.Nihon kohden technical support (tech support) assisted in changing the patient information.No patient harm reported.

• Brand Name: EEG-1200A
• Common Device Name: 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10776084
• Report Number: 8030229-2020-00653
• Device Sequence Number: 4178174
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K080546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2020
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown