MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY ROOT WITH NONINVASIVE NLOOD PRESSURE AND TEMPERATU; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9695
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per 21 cfr part 803, the reported issue by the user facility does not meet the requirements for medical device reporting.The narrative provided by the user facility is not related to an adverse event.Rather, it is a description of an interaction the customer experienced associated with a reported shipment delay of the replacement root devices.Reported issue is not product performance related.
Event or Problem Description
Per medwatch report# (b)(4), the customer reported "we have sent several masimo root 7 patient monitors in for repair and have experienced extended time for return of these devices.On average we are having to wait 6-8 weeks for a replacement which is just that, a new unit sent to us and not the device sent in for repair.The new unit isn't an issue for us, but the excessive turn-around time for this device is.We have two spare monitors on hand to make sure we aren't down a room, but those units were put in place and an additional unit was sent out for repair putting us down three units with little to no response from masimo when an inquiry was made about a status update.This lack of supplies and equipment replacement is starting to cause the potential interruption to patient care within our facility." there was no patient impact or consequence reported.

• Brand Name: ROOT WITH NONINVASIVE NLOOD PRESSURE AND TEMPERATU
• 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 - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 21020678
• Report Number: 3019388613-2024-00157
• Device Sequence Number: 4223344
• Product Code: MWI
• UDI-Device Identifier: 00843997011907
• UDI-Public: 00843997011907
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 9695
• Was Device Available for Evaluation?: No
• 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: 12/06/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown