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

Model Number	4248-3
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported lower psi value than normal range.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: : the returned sensor was evaluated.Visual inspection upon receiving revealed no external damage or defects.However, the pads on the electrodes were removed and there was fiber remains from the pads and dried gel deposits on the electrodes.A continuity test across the surface of the electrodes was conducted after removing the fibers and the dried gel deposits.A good continuity was observed across electrodes r1, r2, l1, l2, cb, and ct and between the 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.Customer's complaint was not duplicated., corrected data: model # was corrected from 4248 to 4248-3.
Event or Problem Description
The customer reported lower psi value than normal 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 1604
• MDR Report Key: 8812552
• Report Number: 3011353843-2019-00006
• Device Sequence Number: 19476952
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 09/01/2020
• Device Model Number: 4248-3
• Device Catalogue Number: 4248
• Device Lot Number: 19C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/20/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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: RD SEDLINE PATIENT CABLE; RD SEDLINE PATIENT CABLE