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

Model Number	4248
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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
It was reported "psi shows too high value while patient was anesthetized." no consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During this evaluation, the sensor passed visual inspection; however, failed continuity testing due to open r1, r2, l1, l2, cb, ct across the electrodes.Additionally, the sensor was returned used and could not be tested on forehead.Corrected data: (procode): updated from "dqa" to "mwi".

• Brand Name: SEDLINE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7233096
• Report Number: 2031172-2018-00037
• Device Sequence Number: 1274298
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• 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
• Device Catalogue Number: 2479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/07/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1