MAUDE Adverse Event Report: MASIMO - 40 PARKER ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATU; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	25930
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The device turned on using battery and ac power.The device was found to visually and audibly alarm during alarm conditions.A comparison test was performed of the customer returned device against a masimo test device.The readings were taken 3 times for each device.The customer device displayed measurements that are comparable to the test device.Internal visual 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 root device is fully functional.
Event or Problem Description
The customer reported the device is not reading correctly and the blood pressure reading is inconsistent.No patient impact or consequences were reported.

• Brand Name: ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATU
• 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: 8521044
• Report Number: 2031172-2019-00204
• Device Sequence Number: 1465760
• Product Code: MWI
• UDI-Device Identifier: 00843997011907
• UDI-Public: 00843997011907
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 25930
• Device Catalogue Number: 9695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1