MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY SEDLINE PATIENT CABLE; ELECTROENCEPHALOGRAPH

Model Number	23858
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned cable was evaluated and found to be functioning as designed.All electrodes displayed color green on monitor, indicating electrode impedance was within the acceptable range.No red lines across the field were observed.No product performance issue identified, based on the investigation above, the customer complaint could not be duplicated.
Event or Problem Description
The customer reported the following issue: "dsa display showed red lines across the field, not having seen this pattern before, physician called me in the room to verify the information, i guided him to check lead placement, and proceeded to exchange the patient cable, at which point the problem was resolved.Picture attached.Troubleshooting steps: the patient sensor was changed, lead placement was confirmed, but, same bad results.Dsa continued to show altered.Changed patient cable, and dsa showed more in according to clinical scenario.Never changed the sedline module, but changing the sedline patient cable solved the issue." no consequences or impact to patient were reported.

• Brand Name: SEDLINE PATIENT CABLE
• Common Device Name: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 6734965
• Report Number: 2031172-2017-00734
• Device Sequence Number: 13673560
• Product Code: GWQ
• UDI-Device Identifier: 00843997007955
• UDI-Public: 00843997007955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial

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: Health Professional
• Device Model Number: 23858
• Device Catalogue Number: 3637
• Device Lot Number: A16M058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1