MAUDE Adverse Event Report: ST. JUDE OXIMETER

Model Number SP02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Arrest (4461)

Event Type  Injury  

Event Description

Patient had procedure of system (generator and leads from a competitor) extraction completed by physician prophylactically.Post-operatively, the patient was reported by facility staff to have stopped breathing before the patient reached the recovery room.Resuscitation interventions were attempted by facility staff.Patient was declared deceased.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17490228
• MDR Text Key: 320698588
• Report Number: MW5122738
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SP02
• Patient Sequence Number: 1