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

Model Number	25949
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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 psi was higher than the normal range and when the device was changed the values were in the normal range.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the psi was higher than the normal range and when the device was changed the values were in the normal range.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 unable to power on using battery power but turned on using ac power.Once the battery was charged it could be used for subsequent testing.With a known good radical-7 docked into the root the device was able to obtain readings and alarmed audibly and visually under alarm conditions.Psi measurement comparison testing was completed and the returned device functioned comparably to a known good device.No issues related to measurement accuracy were identified, the device is fully functional.

• 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: 8584307
• Report Number: 2031172-2019-00237
• Device Sequence Number: 19642322
• 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): 04/15/2019

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: 25949
• Device Catalogue Number: 9515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1