MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY ROOT WITH NONINVASIVE BLOOD PRESSURE AND TEMPERATU; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	26224
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
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 device provides blood pressure readings that are off by 10 to 15 points.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.External visual inspection showed no damage.The device was able to turn on using both ac and battery power.The unit was able to obtain readings and alarmed audibly and visually under alarm conditions.Comparison testing was performed between the returned customer device and a masimo test device, the displayed readings were comparable between the two devices.No critical errors were found in the device log file.The customer complaint was not duplicated, the device is fully functional.
Event or Problem Description
The customer reported the device provides blood pressure readings that are off by 10 to 15 points.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 - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 8955867
• Report Number: 3011353843-2019-00047
• Device Sequence Number: 13975198
• Product Code: MWI
• UDI-Device Identifier: 00843997011907
• UDI-Public: 00843997011907
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/09/2019

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: 26224
• Device Catalogue Number: 9695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1