MAUDE Adverse Event Report: ELECTRICAL GEODESICS, INC. GES 400; 256 CHANNEL GES400 CLINICAL EEG SYSTEM W/IMAC

Lot Number	ZZ-01 03/29/16 8:29
Medical Device Problem Codes	Break (1069); Solder Joint Fracture (2324); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Previous mdr 3001090553-2018-00001 was submitted for a similar failure.No injury was reported in the previous mdr however the potential for injury was identified.For this mdr report, the device was not returned to the manufacturer however three high resolution photos were provided by the customer.These photos clearly show the bottom portion of the camera pole and the mount.The photos readily show the clean breakage of all four welds.No deformation or missing material was noted.Internal review confirmed this system was fitted with a camera pole from a previously reviewed lot of camera poles received from a 3rd party vendor, zz-01 3/29/16 8:29.Scar 18-2004 was issued and the vendor responded with the root cause as a lack of weld penetration due to either incorrect equipment settings or operator technique.To address this root cause, the vendor enacted the following corrective actions: operator weld certification upon hire & annual recertification; introduction of equipment settings verification for each run via a pull test of welded test plate and institution of a 100% visual inspection by qc inspectors.No additional lots of camera poles were obtained from this vendor.A redesign of the ges 400 cart w/camera pole has been completed via a different vendor in (b)(6) 2019.
Event or Problem Description
The ges400 system was being transported via the ges400 cart along the corridor when the clinician was moving to the clinic's monitoring unit.During this transport, the camera pole detached from the cart and fell to the ground immediately.There was no shrapnel as the break was clean from the weld.The ges400 system was not in use at the time of the camera pole mechanical failure.There was no allegation of patient or user injury.

• Brand Name: GES 400
• Common Device Name: 256 CHANNEL GES400 CLINICAL EEG SYSTEM W/IMAC
• Manufacturer (Section D): ELECTRICAL GEODESICS, INC.; 500 east 4th avenue; suite 200; eugene OR 97401
• MDR Report Key: 9195123
• Report Number: 3001090553-2019-00001
• Device Sequence Number: 13966869
• Product Code: GWQ
• UDI-Device Identifier: 00863003000305
• UDI-Public: 00863003000305
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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
• Operator of Device: Other
• Device Lot Number: ZZ-01 03/29/16 8:29
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1