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.

• 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: 11572948
• MDR Text Key: 245979732
• Report Number: 8030229-2021-00174
• Device Sequence Number: 1
• Product Code: OLT
• 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
• Report Date: 03/25/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2021
• 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