MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE SENSOR; ELECTROENCEPHALOGRAPH

Model Number	2479
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported psi too high during use (more than 90 though pt.Was well anesthetized).No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.No physical damage was observed during external visual inspection.The sensor failed continuity testing due to open circuits found across all electrodes.The sensor was returned used and thus could not be tested on forehead.Corrected data: expiration date corrected to 10/01/2019.

• Brand Name: SEDLINE SENSOR
• Common Device Name: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6806442
• Report Number: 2031172-2017-00795
• Device Sequence Number: 969533
• Product Code: GWQ
• UDI-Device Identifier: 10843997005804
• UDI-Public: 10843997005804
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup

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 Expiration Date: 10/01/2019
• Device Model Number: 2479
• Device Catalogue Number: 2479
• Device Lot Number: 17B29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 08/19/2017
• Supplement Report FDA Received Date: 09/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1