MAUDE Adverse Event Report: MAQUET MAQUET ACROBAT SUV; ACROBAT SUV VACUUM OFF PUMP SYSTEM

Model Number OM 9000S

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 02/16/2018

Event Type  Injury  

Event Description

Dr attempted to release the clamp on the device, the clamp hardware failed and became detached from either end of the two pieces of the clamp.No apparent injuries to the pt.

• Brand Name: MAQUET ACROBAT SUV
• Type of Device: ACROBAT SUV VACUUM OFF PUMP SYSTEM
• Manufacturer (Section D): MAQUET ; 45 barbour pond dr.; wayne NJ 07470
• MDR Report Key: 7317043
• MDR Text Key: 101778497
• Report Number: MW5075708
• Device Sequence Number: 1
• Product Code: NQG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: OM 9000S
• Device Lot Number: 25134992
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR