MAUDE Adverse Event Report: MASIMO - 40 PARKER SEDLINE KIT; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	25871
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
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 the psi value did not go down into normal range.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned module was evaluated.Visual inspection upon receiving revealed no external damage or defects.Customer module was functionally tested.Artifacts alternate between 0% and 100% and psi value alternates between 0% and a blank value.The failure was isolated to a component (u2) on the digital board.A service history record review reveals that this unit was in the field for over eight (8) months with no previous reported issues prior to this reported event.
Event or Problem Description
The customer reported the psi value did not go down into normal range.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 - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8746274
• Report Number: 2031172-2019-00315
• Device Sequence Number: 2040633
• Product Code: MWI
• UDI-Device Identifier: 00843997009096
• UDI-Public: 00843997009096
• 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
• Report Date (Section B): 06/11/2019

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: 25871
• Device Catalogue Number: 9513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/29/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1