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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 Problem Unintended System Motion (1430)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6) 2015 04:28 pm (gmt-5:00) added by (b)(6) ((b)(4)): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, acrobat istabilizer would not tighten down with the knob, it would just freely spin.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
On (b)(6) 2016 05:13 pm (gmt-5:00) added by (b)(6) ((b)(4)): the device was returned to the factory for evaluation.Signs of blood and clinical use were observed.A visual inspection was conducted.There were no observable defects.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm did not tighten and lock the device when the tightening knob was turned clockwise.Based the returned condition of the device and results of the investigation the reported complaint was confirmed.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, acrobat istabilizer would not tighten down with the knob, it would just freely spin.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key5250569
MDR Text Key32237339
Report Number2242352-2015-01308
Device Sequence Number1
Product Code MWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Catalogue NumberC-OM-10000
Device Lot Number25118479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2015
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received02/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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