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

Model Number EEG-1200A

Device Problems Application Program Problem (2880); Output Problem (3005)

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

Event Date 10/03/2020

Event Type  malfunction  

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 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.

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 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
• 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 ; 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
• MDR Text Key: 219517470
• Report Number: 8030229-2020-00653
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• 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