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

Model Number	25223
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
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 the nibp disappears from the display intermittently.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the nibp disappears from the display intermittently.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection showed no damage.The device passed all functional testing.Nibp measurements were obtained multiple times and the measurements didn't disappear from the screen during testing.The returned device was configured differently to the customer's safetynet settings.The device was able to connect to the test safetynet and measurements displayed on the screen without disappearing.The customer complaint was not duplicated however the safetynet settings could have caused the readings to disappear from the safetynet display., corrected data: device available for evaluation? was updated from yes, date returned 24-may-2019 to 23-may-2019.

• 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: 8674854
• Report Number: 2031172-2019-00278
• Device Sequence Number: 19426184
• 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,Followup
• Report Date (Section B): 05/17/2019

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: 25223
• Device Catalogue Number: 9695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1