MAUDE Adverse Event Report: ST. JUDE MEDICAL CLAMP, VASCULAR; FEMOSTOP COMPRESSION DEVICE

Lot Number RHM02750

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/10/2020

Event Type  malfunction  

Event Description

Femostop compression device attempted and error message received.Error message "e05" error code looked up "too low battery voltage".Fda safety report id# (b)(4).

• Brand Name: CLAMP, VASCULAR
• Type of Device: FEMOSTOP COMPRESSION DEVICE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 10055648
• MDR Text Key: 191117370
• Report Number: MW5094487
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: RHM02750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR