MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE SENSOR; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	2479
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.
Event or Problem Description
The customer reported patient is anesthetized enough but psi showed high.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the unit failed continuity testing due to an open connection on r1, r2, l2, cb, and ct electrodes.Visual inspection confirmed there is no physical damage.Functional testing could not be performed since the sensor was returned used and could not be tested on the forehead., (brand name) was updated from "sedline" to "sedline sensor", (common device name) was updated from "electroencephalograph" to "monitor, physiological, patient (without arrhythmia detection or alarms)", (procode) was updated from "gqw" to "mwi", (expiration date) was updated from a blank field to "10/01/2019", (report source) was updated from " foreign; health professional; user facility", to "foreign; company representative; user facility".

• Brand Name: SEDLINE SENSOR
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6806473
• Report Number: 2031172-2017-00799
• Device Sequence Number: 819203
• Product Code: MWI
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• 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: 08/08/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/19/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1