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

Catalog Number 4003

Device Problem Sensing Intermittently (1558)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2023

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.

Event Description

The customer reported the pulse ox probe stopped reading twice within 30 minutes.Monitor appeared with question mark.There were no patient impact or consequences reported.

• Brand Name: RD SET NEO
• Type of Device: 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17814550
• MDR Text Key: 324231311
• Report Number: 3019388613-2023-00236
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: 10843997009598
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4003
• Device Lot Number: 22NCJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1