MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-57 PULSE CO-OXIMETER

Model Number	9216
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rad-57 "was on a patient and stopped working without warning, [and] no longer will power on now." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Masimo has reached out to the customer to request the return of the device.The product has not been returned to masimo to allow an analysis to be performed.If the product 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).
Event or Problem Description
The customer reported the rad-57 "was on a patient and stopped working without warning, [and] no longer will power on now." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned rad-57 was evaluated.The device was unable to power on via battery power due to foreign contaminant on the power button.When a known good keypad was installed, the device was able to power on and functioned as designed.The keypad contaminant on the power button did not impact the device's ability to alarm.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).Heath effect impact code: no adverse event; no patient impact.

• Brand Name: RAD-57 PULSE CO-OXIMETER
• 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: 21360593
• Report Number: 3019388613-2025-00010
• Device Sequence Number: 12902624
• Product Code: DQA
• UDI-Device Identifier: 00843997006163
• UDI-Public: (01)00843997006163(11)110208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080238
• 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): 01/24/2025

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: 9216
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2011
• 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