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

Model Number	25926
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported the root screen is freezing during monitoring with sedline module.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the root screen is freezing during monitoring with sedline module.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The device turned on using battery and ac power and remained on during switching from battery power to ac power.The root displayed an error message ¿no sd card¿ and emitted 12 flash watchdog alarm.The sd card was found ejected.After installing the micro sd card into the root, it was fully functional and was able to obtain and display spo2 and pulse rate readings without the screen freezing.The device was found to visually and audibly alarm during alarm conditions.The customer complaint was not duplicated but the most probable cause was identified.The ejected sd card most likely caused the customer complaint which was not observed during the investigation.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., corrected data: d11 concomitant medical products was updated from "sedline module" to "sedline and o3 module".

• 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: 8676939
• Report Number: 2031172-2019-00281
• Device Sequence Number: 11500064
• Product Code: MWI
• UDI-Device Identifier: 00843997008280
• UDI-Public: 00843997008280
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 25926
• Device Catalogue Number: 9515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEDLINE AND O3 MODULE; SEDLINE MODULE