MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY KIT, RAD-97 PULSE CO-OXIMETER

Model Number	27572
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported speaker error, was not possible to hear sound from the device.No patient impact or consequences were reported.
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.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.The device powers on and then there is an audio speaker fault with a 7 beep audible alarm with flashing red power button led.During internal inspection, the speaker was replaced but the error remained.The instrument board was replaced and the device was able to function as designed.The instrument board component u13 receives correct input signals but does not output ¿audio_l" signal.Prevents main speaker from outputting sound.Causes the device to give an audio speaker fault message with audible (from onboard buzzer) and visual alarms (from power button led).A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported speaker error, was not possible to hear sound from the device.No patient impact or consequences were reported.

• Brand Name: KIT, RAD-97 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 14598618
• Report Number: 3019388613-2022-00130
• Device Sequence Number: 5946366
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: 00843997012317
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170168
• 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): 05/10/2022

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: 27572
• Device Catalogue Number: 9738
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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