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

Model Number	4248
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection found no physical damage.The pads on the electrodes were removed and fiber remains from pads and dried gel deposits were observed on the electrodes.Continuity testing across the surface of the electrodes found an open circuit across all of the electrodes.The gel and fiber residue was removed and good continuity was found across the electrodes.Continuity testing was performed between the electrodes surface and the connector and found an open circuit between the ct electrodes and the connector.The sensor was returned used.Functional testing could not be performed since the sensor is intended for single-patient use; the integrity of the sensor (gel; contacts; etc) is broken once it is removed from patient use.The sedline sensor couldn¿t be detected due to an open circuit between ct electrode and the tip of the connector.
Event or Problem Description
The customer reported the patient state index (psi) was not in the expected range.No patient impact or consequences were reported.

• Brand Name: RD SEDLINE SENSOR
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9832858
• Report Number: 3011353843-2020-00034
• Device Sequence Number: 14177163
• Product Code: MWI
• UDI-Device Identifier: 10843997011775
• UDI-Public: 10843997011775
• 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
• Report Date (Section B): 02/20/2020

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: 12/01/2020
• Device Model Number: 4248
• Device Catalogue Number: 4248
• Device Lot Number: 19GDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1