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

Model Number EEG-1200A

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.The unit was in use on patients at the time, but no patient harm was reported.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.

Manufacturer Narrative

Complaint information: on 05/15/2018, customer at (b)(6) medical center reported ups started smoking during eeg examination.The serial# of ups was (b)(6) with product id: a/abce422-11med service requested: assistance in troubleshooting.Service performed: customer reports that during an eeg, the ups started smoking and then they had to call a code orange and evacuate the room.Nkts requested customer to send ups unit in to repair center and escalated the issue to qa for further investigation.Investigation result: root cause of the issue as per the manufacturer findings was deeply discharged batteries (battery connected without ac power for an extended period of time).When power was applied to the upm, the batteries were in a defective state and swelled.The unit will charge the battery that is weakened, this leads to failure in the battery, causing the battery to exceed battery design limits causing expansion and venting.According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: medium.Corrective and preventative actions taken: manufacturers have updated firmware to detect severely depleted batteries.The user will be alerted visually via the front panel display.All icons on the display will cycle on and off.The display will continue until the battery is disconnected or ac removed.A field bulletin has been issued describing what steps need to be taken.D11 & c2: the eeg that was being used with the ups had no issue.The issue is with the ups that was being used in conjunction with the eeg.Model: a/abce422-11med.Serial: (b)(6).

Event Description

The biomedical engineer reported that the ups started smoking during the use of the eeg-1200a.

• 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
• MDR Report Key: 7598830
• MDR Text Key: 111150806
• Report Number: 8030229-2018-00207
• Device Sequence Number: 1
• Product Code: OLT
• UDI-Device Identifier: 04931921110904
• UDI-Public: 4931921110904
• Combination Product (y/n): N
• PMA/PMN Number: K080546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Distributor Facility Aware Date: 02/06/2020
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: UPS