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	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the maximum allowable characters; zip code 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.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported that the device is "getting on off automatically".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.During evaluation, the device was found to have a short across the power button of the device.This short results in the power button being activated even when not physically pressed.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).Masimo initiated a recall for this issue and notified us fda on 2/15/2024.The recall number is z-1538-2024.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported that the device is "getting on off automatically".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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22173071
• Report Number: 3019388613-2025-00041
• Device Sequence Number: 13075247
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: (01)00843997000666(11)230301
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 04/16/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1538-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown