MAUDE Adverse Event Report: COVIDIEN NELLCOR NEONATAL SPO2 SENSOR; OXIMETER

Model Number	MAXN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Spo2 sensor was removed from packaging during code lily and the adhesive band fell apart.

• Brand Name: NELLCOR NEONATAL SPO2 SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 18650325
• Report Number: MW5151079
• Device Sequence Number: 20627933
• Product Code: DQA
• UDI-Device Identifier: 20884522041727
• UDI-Public: (01)20884522041727
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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: MAXN
• Device Lot Number: 1308051X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American