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

Model Number EEG-1200A

Device Problem Mechanical Problem (1384)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The eeg tech reported that the caster on cart for the eeg system came off.They stated that the bolt that held the caster in place sheered and caused it to fall off.No patient harm or injury reported.Nihon kohden continues to investigate the reported event.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 that the caster on cart for the eeg system came off.They stated that the bolt that held the caster in place sheered and caused it to fall off.No patient harm or injury reported.

Manufacturer Narrative

Details of complaint: caster fell off cart.Customer called because one of the casters on the cart came off.She had stated that the bolt that held the caster in place sheered and caused it to fall off.Nka does not stock replacement wheels.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: ts has reached out to the customer multiple times requesting model number and sn, including a picture.This information was not provided by the customer and was eventually told that the biomed was able to fix the cart.Ts asked for the cart information and she said she was unable to provide me with that information.

Event Description

The eeg tech reported that the caster on cart for the eeg system came off.They stated that the bolt that held the caster in place sheered and caused it to fall off.No patient harm or injury reported.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) reported the caster on the eeg cart came off (eeg-1200a-raid sn: (b)(6) ).The bolt that held the caster in place sheared and caused it to fall off.Service requested: troubleshooting/assistance.Service performed : customer was advised nka does not stock casters to replace on carts.Bme was able to fix the cart.Customer was unable to provide the cart information after multiple follow up attempts from nka ts.Investigation result cart information was unavailable.Details surrounding the incident, including pictures of the caster, was not provided.Customer was able to resolve the issue internally without nka assistance.Eeg warranty began 10/28/2015.The issue occurred after 3 years at customer facility.Review of eeg sap history found no reported issues with the unit.Based on the information provided by the customer, investigation is limited and the root cause could not be determined.The issue involved condition of the physical eeg cart and there was no reported issue with functionality of the eeg system.Review of tickets opened at (b)(6) found no additional issues reported relating to "caster".Investigation conclusion: based on the information provided by the customer, investigation is limited and the root cause could not be determined.The issue involved condition of the physical eeg cart and there was no reported issue with functionality of the eeg system.Review of tickets opened at (b)(6) hospital found no additional issues reported relating to "caster".

• 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: 8220331
• MDR Text Key: 132513778
• Report Number: 8030229-2019-00002
• 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,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2020
• Distributor Facility Aware Date: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1