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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Catalog Number C-UA-5001
Device Problem Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Retractor arm had gapping at the joints.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint # (b)(4).Autonumber # (b)(4).The complaint is a duplicate of another complaint (b)(4) and therefore is being canceled.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech.Retractor arm had gapping at the joints.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
Type of Device
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8187651
MDR Text Key131144181
Report Number2242352-2018-01346
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/20/2018
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
Device Operator Health Professional
Device Catalogue NumberC-UA-5001
Device Lot Number25081546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/20/2018
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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