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

Model Number	4005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the sensor was returned to masimo for evaluation.The visual inspection confirmed a lifted flex cable at the rd15 connector.No continuity or functional testing was conducted as the damages prevented the sensor from being able to connect the sensor onto the tester.
Event or Problem Description
The customer reported per the medwatch notification "monitor read equipment malfunction and the patient's oxygen saturation stopped reading.Upon inspecting faulty pulse oximeter, registered nurse (rn) noticed the black and gold area, the end that connects into the monitor end, had peeled up and was bent." there was no patient impact or consequences reported.

• Brand Name: RD SET NEOPT-500
• 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: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19226480
• Report Number: 3019388613-2024-00054
• Device Sequence Number: 18261077
• Product Code: DQA
• UDI-Device Identifier: 10843997009895
• UDI-Public: 10843997009895
• 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
• Report Date (Section B): 04/09/2024

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 Expiration Date: 09/01/2025
• Device Model Number: 4005
• Device Catalogue Number: 4005
• Device Lot Number: 22JTU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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