MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEOPT-500 NON-ADHESIVE SENSOR; OXIMETER

Model Number	4005
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the masimo representative 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.As no lot number information was available for the cable, only the device identifier (01) portion of the udi is provided in this follow-up mdr.The production identifiers pertaining to expiration date (17) and batch/lot number (10) could not be included in the udi as they are indeterminable.Product not returned.
Event or Problem Description
The customer reported "patient's monitor came had a warning that said "spo2 replace sensr".Sensor was replaced and the warning went away." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was confirmed to be functioning as designed.This supplemental form also updates the lot number and udi production identifiers pertaining to expiration date (17) and batch/lot number (10).
Event or Problem Description
The customer reported "patient's monitor came had a warning that said "spo2 replace sensr".Sensor was replaced and the warning went away." there was no patient impact or consequence reported.

• Brand Name: RD SET NEOPT-500 NON-ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEDICAL TECHNOLOGIES (MALAYSIA) SDN BHD; lot 198512, (plo 547-b) jalan keluli 11, zon 12a; kawasan perindustrian pasir gudang 81700 ; MY 81700
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 19801273
• Report Number: 3019388613-2024-00099
• Device Sequence Number: 18239828
• Product Code: DQA
• UDI-Device Identifier: 10843997009895
• UDI-Public: (01)10843997009895(17)270301(10)E24CS4
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 4005
• Device Lot Number: E24CS4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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