MAUDE Adverse Event Report: MASIMO CORPORATION RD SET; OXIMETER

Model Number 4478

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Device Sensing Problem (2917); Temperature Problem (3022); Unexpected Shutdown (4019)

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

Event Date 09/24/2022

Event Type  malfunction  

Event Description

Multiple events: masimo sensors 4478 and 4477- exposed wires, 1 complaint of wire being hot, shutting off unexpectedly, difficulty picking up saturations, unreliable saturation rates.Masimo sensor 4013- difficulty picking up saturations, unreliable saturation rates.All saved defective wires were returned to mfg.Masimo.

• Brand Name: RD SET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 9600 jeronimo; irvine CA 92618
• MDR Report Key: 16277067
• MDR Text Key: 308541444
• Report Number: 16277067
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1