MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET NEO; OXIMETER

Model Number	4003
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: the product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported they are experiencing low spo2 values without any reason.No patient impact or consequences were reported as part of this complaint.
Event or Problem Description
The customer reported they are experiencing low spo2 values without any reason.No patient impact or consequences were reported as part of this complaint.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: it was reported the device was received at a masimo international facility.Additional information was obtained that during shipping the device was lost by the third party shipping company.Since the product involved in this event will not be returned to the investigational facility, an analysis could not be performed., corrected data: d10 device available for evaluation updated from "yes, (b)(6) 2021" to "no".H3 device evaluated by manufacturer updated from "no, device evaluation anticipated, but not yet begun" to "other reason for non evaluation" h3 other text : device not received at investigation facility.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed.  .
Event or Problem Description
The customer reported they are experiencing low spo2 values without any reason.No patient impact or consequences were reported as part of this complaint.

• Brand Name: RD SET NEO
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; 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 ; 52 discovery; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12184862
• Report Number: 3011353843-2021-00164
• Device Sequence Number: 936559
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: 10843997009598
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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 Expiration Date: 08/01/2023
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Device Lot Number: 20HUK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 01/13/2022
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 10/07/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• 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