MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FEMOSTOP¿; CLAMP, VASCULAR

Model Number GOLD

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

The fem-stop gold femoral compression system malfunctioned- "when the red tab was pulled, the lcd display didn't work- staff was unable to change the pressure settings.".

• Brand Name: FEMOSTOP¿
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2305 walnut street; roseville MN 55113
• MDR Report Key: 9473559
• MDR Text Key: 170913416
• Report Number: 9473559
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GOLD
• Device Catalogue Number: C11165
• Device Lot Number: 6964786
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1