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

Model Number	OM-9000Z
Medical Device Problem Codes	Mechanical Problem (1384); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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.H3 other text : device not returned.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat suv stabilizer system om-9000z, they tried to fix it to the anastomosis site of the coronary artery, but it could not be fixed because the suction pressure was minus 400mmhg.It did not adsorb.It is considered that there was a problem with the suction.Swivel is no problem.The retractor lock was fine.Surgery was completed using the new om-9000z.No procedural delay.There were no effects on patients.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 3000269996 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Additional Manufacturer Narrative
(b)(4).Corrected sections: h6--problem code corrected from "1384" to "4039".
Event or Problem Description
N/a.

• Brand Name: ACROBAT SUV STABILIZER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17438904
• Report Number: 2242352-2023-00646
• Device Sequence Number: 14124927
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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: 09/27/2024
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000269996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 09/18/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/28/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown