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

Model Number	25926
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
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 psi wasn't measured correctly with this device.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.The device was able to power on using both ac and battery power.A known good sedline module was connected to the device and was able to obtain readings with a test plug.No artifacts, abnormal signals, errors or interruptions in monitoring were observed.The cable was bent with no loss of signal.Alarms are fully functional.Obtained psi values were comparable to a known good device.Internal inspection showed no damage or defects.The device is fully functional, no performance issues were observed.
Event or Problem Description
The customer reported psi wasn't measured correctly with this device.No patient impact or consequences were reported.

• Brand Name: ROOT
• 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: 8700348
• Report Number: 2031172-2019-00292
• Device Sequence Number: 1924905
• Product Code: MWI
• UDI-Device Identifier: 00843997008280
• UDI-Public: 00843997008280
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140188
• 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): 05/23/2019

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: 25926
• Device Catalogue Number: 9515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1