MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT SUV STABILIZER SYSTEM; STABILIZER, HEART

Model Number	ACROBAT SUV STABILIZER SYSTEM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat suv stabilizer system.They turned the handle to fix the arm of om-9000s, but the handle became loose and could not be fixed.Completed ope using another lot om-9000s.There was no particular effect on patients such as delays in surgery.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
N/a.

• Brand Name: ACROBAT SUV STABILIZER SYSTEM
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 11731279
• Report Number: 2242352-2021-00314
• Device Sequence Number: 4027249
• Product Code: MWS
• UDI-Device Identifier: 00607567700543
• UDI-Public: 00607567700543
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2021
• Device Model Number: ACROBAT SUV STABILIZER SYSTEM
• Device Catalogue Number: C-OM-9000S
• Device Lot Number: 25145720
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1