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

Model Number	26619
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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 psi was higher than the normal range.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.Masimo sedline module and customer cable were connected to masimo root and functionally tested.Waveform and measurement values, including emg, dsa and psi were displayed with sedline test plug.No artifacts or abnormal signals were observed.No errors or interruptions to measurements were observed.No loss of measurements with cable bending.Alarms were functional.The module was tested for 5 minutes continuously and no errors were observed.The module passed psi comparison measurements.Visual internal inspection was performed.No internal circuitry damage or defects were observed.No loose cabling or loose circuit board to circuit board interconnections were observed.Customer complaint was not duplicated.The module was found to be fully functional., corrected data: d4 model # was updated from 9513 to 26619.
Event or Problem Description
The customer reported the psi was higher than the 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 - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 8729701
• Report Number: 2031172-2019-00306
• Device Sequence Number: 16645062
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 26619
• Device Catalogue Number: 9513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1