MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY ROOT; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9515
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: the returned root device was evaluated.The heat damage was contained to the inside the device housing.Due to the extent of the heat damage, a root cause cannot be determined.However, since the majority of the damage was around the battery compartment, a potential root cause could be from a battery failure.Other devices (radical-7, sedline module, o3 module, and a patient cable) associated with this reported incident were returned.These were also investigated and confirmed to be functioning as designed.Masimo devices are designed to comply with iec 60601-1 to minimize potential end user impact in the event of an electrical fault.The root device is also designed with pwb (printed wiring board) that is ul rated min.105°c and flame rated min.V-2 to reduce the risk of deformation from heat and reduce the probability for the spread of fire.An extensive review of the complaint history on the root devices confirmed this was an isolated report, and the only such occurrence reported since the launch of the product in 2014.
Event or Problem Description
The customer reported the "root went [on] fire.Device was off and not power connected." there was no patient impact or consequences reported.

• Brand Name: ROOT
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 20611619
• Report Number: 3019388613-2024-00130
• Device Sequence Number: 12610769
• Product Code: MWI
• UDI-Device Identifier: 00843997008280
• UDI-Public: (01)00843997008280(11)171204
• Combination Product (Y/N): N
• PMA/510(K) Number: K110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

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: 9515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADICAL-7, SEDLINE/O3 MODULE, AND MD20-12 CABLE.
• Patient Sex: Unknown