MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-5 PULSE OXIMETER

Model Number	26818
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).Device not returned.
Event or Problem Description
The customer reported the rad-5 loud speaker "no longer emits any sounds." no patient impact or consequences were reported.
Event or Problem Description
The customer reported the rad-5 loud speaker "no longer emits any sounds." no patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.The completed failure analysis determined the rad-5 speaker was not emitting sound due to the u5 component of the instrument board not sending an output signal to the speaker.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).

• Brand Name: RAD-5 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16304539
• Report Number: 3019388613-2023-00022
• Device Sequence Number: 5978101
• Product Code: DQA
• UDI-Device Identifier: 00843997005913
• UDI-Public: 00843997005913
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033296
• 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): 01/12/2023

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: 26818
• Device Catalogue Number: 9214
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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