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

Model Number	4248-9
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.External visual inspection showed the r2 electrode was detached.The sponge pads on the electrodes were removed, fiber remains on the pads and dried gel deposits were observed on the electrodes.The sensor failed continuity testing due to an open circuit across all the electrodes.Gel and fiber residue removed and continuity testing was redone.Good continuity was observed all of the electrodes.Continuity test was performed between the electrodes and the connector and an open was observed between the r2 connector and the electrode.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.
Event or Problem Description
The customer reported the device provided inaccurate psi values.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 1604
• MDR Report Key: 8897878
• Report Number: 3011353843-2019-00037
• Device Sequence Number: 13857476
• 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): 07/26/2019

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 Expiration Date: 06/01/2020
• Device Model Number: 4248-9
• Device Catalogue Number: 4248
• Device Lot Number: 18NHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1