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

Model Number	25761
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the device provided inaccurate measurements.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.Visual inspection upon receipt revealed no external damages.During functional testing, the module was unable to establish connection to a known-good root device.Internal inspection isolated the failure to multiple damaged circuit board cables, which were determined to be the cause of the "error port" message.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported that the device provided inaccurate measurements.No consequences or impact to patient 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: 8536128
• Report Number: 2031172-2019-00209
• Device Sequence Number: 13546463
• Product Code: MWI
• UDI-Device Identifier: 00843997009096
• UDI-Public: 00843997009096
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 25761
• Device Catalogue Number: 9513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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