MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-8 HORIZONTAL SIGNAL EXTRACTION PULSE OXIMETER

Model Number	9190
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rad-8 turns off automatically after 10 minutes.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received 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-8 turns off automatically after 10 minutes.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated, and the device battery was unable to hold its charge.This results in the unit powering off with a low battery alarm.

• Brand Name: RAD-8 HORIZONTAL SIGNAL EXTRACTION PULSE 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: 19742468
• Report Number: 3019388613-2024-00092
• Device Sequence Number: 20747098
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: (01)00843997005647(11)180816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 9190
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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