MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G; OXIMETER

Model Number	9849
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device, cables, and sensor are not expected to be returned to masimo to allow an analysis to be performed.If the products are returned for evaluation or new information is obtained, a follow-up report will be submitted.Health effect impact code: no adverse event, no patient impact d1.Concomitant medical products exceeded allowable field length, concomitant medical products is as follows: lncs sensor (24fw8), g15-05 cable (23e75), and lncs to rd adapter cable e1.Initial reporter address details were not provided.The device, cables, and sensor were provided by the initial reporter's dme, (b)(6)l.As such the facility name (b)(6) was entered in e1.
Event or Problem Description
The customer reported that the rad-g, cables, and sensor are "unreliable" and constantly display 'sensor off patient' ¿pulse search' or 'replace sensor' error messages.Per additional information from the customer, "also, there are times when it does not alarm and i look at the screen and it is a flat line, no telling how long it has not been reading.For a child who is medically complex, has a tracheostomy and is monitored 24/7 with an unreliable pulse ox machine, it could be detrimental to not have accurate and consistent readings." there was no patient impact or consequence reported.

• Brand Name: RAD-G
• Common Device Name: OXIMETER
• 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24750442
• Report Number: 3019388613-2026-00117
• Device Sequence Number: 18713548
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: (01)00843997000666(11)230807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: Lay User/Patient
• Device Model Number: 9849
• Device Catalogue Number: 9849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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