MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY SEDLINE KIT; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	26619
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
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 inaccurate measurements.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sedline module was evaluated.Visual inspection upon receiving revealed no external damage or defects.During evaluation the device passed all functional tests.Psi measurements were comparable to measurements obtained with a known good root and a known good sedline module.No performance issues were observed.There was no loss of measurements during testing even while twisting, shaking and bending the cable.The customer complaint was not duplicated.The sedline module was found to be functioning as designed.
Event or Problem Description
The customer reported inaccurate measurements.No patient impact or consequences were reported.

• Brand Name: SEDLINE KIT
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 9132097
• Report Number: 3011353843-2019-00068
• Device Sequence Number: 2475714
• Product Code: MWI
• UDI-Device Identifier: 00843997009096
• UDI-Public: 00843997009096
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K172890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 26619
• Device Catalogue Number: 9513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROOT; ROOT
• Patient Age: 12 MO