MAUDE Adverse Event Report: MASIMO CORPORATION GE CARESCAPE SP02 - MASIMO RAINBOW SET PULSE CO-OXIMETRY MODULE; OXIMETER

Model Number	4184
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Masimo spo2 brick failed along with cable that plgus into it, said "faulty probe.".

• Brand Name: GE CARESCAPE SP02 - MASIMO RAINBOW SET PULSE CO-OXIMETRY MODULE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 18571320
• Report Number: 18571320
• Device Sequence Number: 15238867
• Product Code: DQA
• UDI-Device Identifier: 00843997010832
• UDI-Public: (01)00843997010832
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 10/04/2023

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: 4184
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• 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: Male
• Patient Weight: 94 KG
• Date Report Sent to FDA: 10/04/2023