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

Model Number	4248-9
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow 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 value doesn't seem accurate.Additionally, the values went up to around 80 without other signs of waking up or muscle movement.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During inspection, the sensor passed visual analysis; however, failed continuity testing due to open l1, l2, r1, r2 across the electrodes.The sensor was returned used and could not be tested on the forehead for functional test., brand name was updated from "sedline eeg sensor" to "rd sedline sensor".Model # was updated from "4248" to "4248-9".Catalog # was updated from "2479" to "4248".Lot# updated from "17n55" to "17k14".Exp.Date was updated from "06/01/2019" to "03/01/2019".Udi # was updated from "1(b)(4)" to "(b)(4)".Device manufacture date was updated from "12/21/2017" to "10/26/2017".

• Brand Name: RD 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: 7405772
• Report Number: 2031172-2018-00214
• Device Sequence Number: 11124369
• Product Code: MWI
• UDI-Device Identifier: 10843997005804
• UDI-Public: 10843997005804
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151644
• 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: 03/01/2019
• Device Model Number: 4248-9
• Device Catalogue Number: 4248
• Device Lot Number: 17K14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/08/2018
• Supplement Report FDA Received Date: 05/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1