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

Model Number EEG-1200A

Device Problem Smoking (1585)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt." qa along with service reviewed the pc and the computer would not turn on, only the amber light was flashing.There was not burning smell.The unit was then evaluated by the service, and they concluded that the power supply was bad.The power supply was replaced and the unit was burned-in for 72 hours and everything tested fine.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt.".

Manufacturer Narrative

Additional information: type of report? if follow-up, what type? details of complaint: customer called and reported her eeg/polysmith system 'popped and started smelling like something was burnt.Unit was sent in for evaluation.Service requested: repair/loaner.Service performed: troubleshooting.Investigation result: reviewed the pc with repair center and the computer would not turn on, only the amber light was flashing.There was no burning smell.Requested the repair center continue with troubleshooting pc.Qa/repair center has evaluated the burning smell that came from power supply burning.Replace the power supply.Reapply the cpu paste.Check the eeg test.

• Brand Name: EEG-1200A
• Type of Device: NEUROFAX ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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: 7087049
• MDR Text Key: 94492408
• Report Number: 8030229-2017-00424
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 04931921110904
• 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: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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: Medical Technologist
• Device Model Number: EEG-1200A
• Device Catalogue Number: EEG-1200A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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