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

Model Number	25926
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
It was reported: "after a few hours root turned off and didn't turn on again." no consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation, the unit was unable to power on using both ac and dc power.No errors were observed in the log files.Internal inspection revealed one of the fuses blown, preventing the root from powering on using ac power.One known good fuse was installed and the unit was able to power on successfully.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues prior to this reported event.
Event or Problem Description
It was reported: "after a few hours root turned off and didn't turn on again." no consequences or impact to patient was 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: 7564144
• Report Number: 2031172-2018-00327
• Device Sequence Number: 14082120
• Product Code: MWI
• UDI-Device Identifier: 00843997008280
• UDI-Public: 00843997008280
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: Other
• Device Model Number: 25926
• Device Catalogue Number: 9515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/03/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1