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

Model Number EEG-1200A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the eeg data recorded under another patient's study node.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 customer reported that the eeg data recorded under another patient's study node.No patient harm or injury reported.

Manufacturer Narrative

H10: additional narrative: the customer reported that their system is recording under incorrect name.Service requested: troubleshooting.Service provided: troubleshooting.Investigation result: the last two studies started on customer's unit were saved under one name.The issue was resolved by ts, starting a new data schedule with the correct patient information, noted the db key and changed the nodes that were incorrectly filed under the wrong patient information.The root cause of the issue was unable to be determined.A review of device history found no previously reported issue with this unit.The customer's issue was resolved and no similar issue was reported subsequent to the resolution.The root cause of the issue could not be determined.Qe investigation for the complaint record has been completed.Corrected information: g4.Date received by manufacturer: should be 11/06/2018 not 12/04/2018 as listed on mdr initial report.Additional information: b4.Date of this report; e1.Initial reporter email; f6.Date user facility/importer became aware of the event; f7.Type of report; f11.Date report sent to fda; f13.Date report sent to manufacturer; g4.Date received by manufacturer; g7.Type of report; h2.If follow-up, what type? additional information correction; h3.Device evaluated by manufacturer? ; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.The following fields do not contain information as this unit is not serialized.Therefore, the following fields do not contain information.D4.Serial #.F9.Approximate age of device.H4.Device manufacture date.

Event Description

The customer reported that the eeg data recorded under another patient's study node.No patient harm or injury reported.

• 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: 8131035
• MDR Text Key: 129601977
• Report Number: 8030229-2018-00461
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Distributor Facility Aware Date: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1