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

Model Number	9849
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).Submission was delayed due to masimo identifying unauthorized activity on the company¿s on-premises network.Upon detection, masimo activated its incident response protocol and incident containment measures including proactively isolating impacted systems, which resulted an inability to access our electronic complaint files preventing us from submitting mdrs on time.H3 other text: product not returned.
Event or Problem Description
The customer reported the rad-g "loses power when moved." no patient impact or consequences were reported.
Additional Manufacturer Narrative
Other text: the returned rad-g was evaluated.The device passed visual and functional testing.The device was able to obtain measurements with all enabled parameters and no interruption to monitoring was observed when the device was moved.The device was determined to be functioning as designed.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(60.E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the rad-g "loses power when moved." no patient impact or consequences were 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22173036
• Report Number: 3019388613-2025-00032
• Device Sequence Number: 9199975
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: (01)00843997000666(11)241023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: Health Professional
• Device Model Number: 9849
• Device Catalogue Number: 9849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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