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

Model Number	24295
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported the sedline (psi) number is dropping out and not showing on the screen.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the sedline (psi) number is dropping out and not showing on the screen.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The module was functionally tested.The module communicated with the root but did not obtain measurement due to high impedance that was detected on channel r2.Internal inspection revealed the sensor connector r2 channel pin was broken away at the solder point.Customer complaint duplicated.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event.Device manufacturer date was updated from "05/11/2018" to "07/13/2017." additional manufacturer narrative was updated from ¿a service history record review reveals that this unit was in the field for over eleven (11) month with no previous reported issues prior to this reported event" to ¿a service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event".
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The module was functionally tested.The module communicated with the root but did not obtain measurement due to high impedance that was detected on channel r2.Internal inspection revealed the sensor connector r2 channel pin was broken away at the solder point.Customer complaint duplicated.A service history record review reveals that this unit was in the field for over eleven (11) month with no previous reported issues prior to this reported event.Model # was corrected from 9513 to 24295.
Event or Problem Description
The customer reported the sedline (psi) number is dropping out and not showing on the screen.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: 8502166
• Report Number: 2031172-2019-00169
• Device Sequence Number: 2758887
• Product Code: MWI
• UDI-Device Identifier: 00843997009096
• UDI-Public: 00843997009096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2019

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: 24295
• Device Catalogue Number: 9513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 05/07/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/03/2019
• 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