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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV ACROBAT-I STABILIZER; STABILIZER,HEART
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MAQUET CV ACROBAT-I STABILIZER; STABILIZER,HEART Back to Search Results
Catalog Number C-OM-10000
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 preparation for a coronary artery bypass procedure, acrobat-i stabilizer when the customer tried to use the device, it was noted that the arm is stiff and hard to move.The customer forced to move the arm and the movement gradually got better.However, there was an obvious difference than normal.The customer continued to use the same device and completed the procedure.No patient injury was reported.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.No visual defects were observed.The biscuit was observed to be intact.The device was evaluated for its mechanical function.With the locking lever engaged and the knob tightened, the biscuit locked in place and could not be moved as expected.When the knob was moved anticlockwise, the biscuit was able to freely move and the arm could be moved side to side, no resistance that can be considered as abnormal was observed.A reference device was used to compare the biscuit and there were no differences observed with the device.Based on the return condition of the device and the results of the evaluation, the reported failure mode "mechanical issue" was not confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, acrobat-i stabilizer when the customer tried to use the device, it was noted that the arm is stiff and hard to move.The customer forced to move the arm and the movement gradually got better.However, there was an obvious difference than normal.The customer continued to use the same device and completed the procedure.No patient injury was reported.
 
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Brand Name
ACROBAT-I STABILIZER
Type of Device
STABILIZER,HEART
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7386643
MDR Text Key104160581
Report Number2242352-2018-00282
Device Sequence Number1
Product Code MWS
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 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2019
Device Catalogue NumberC-OM-10000
Device Lot Number25135319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Date Manufacturer Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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