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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It turns off even if it uses ac adapter.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: device evaluation is anticipated.At the conclusion of our investigation or if new information is obtained, a follow-up report will be submitted.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter address exceeded the maximum allowable characters, address is as follows: (b)(6).E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).
Event or Problem Description
The customer reported that the device turns off even if it uses ac adapter.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: although the product was received at masimo japan's office, the customer requested for the return of the product without any repairs or investigation.The product was sent back to the customer.If new information is obtained, or if the device is sent back in for evaluation, a follow-up report will be submitted.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter address exceeded the maximum allowable characters, address is as follows: (b)(6).E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).H3 other text: customer requested return of device.

• 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: 24477789
• Report Number: 3019388613-2026-00061
• Device Sequence Number: 10221282
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: (01)00843997000666(11)211109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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
• Date Returned to Manufacturer: 02/02/2026
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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