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

Model Number	OM-10000
Medical Device Problem Codes	Suction Problem (2170); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (b)(6) hospital.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that the acrobat-i stabilizer suction function was not working.
Event or Problem Description
The hospital reported that the suction function of the acrobat-i stabilizer was not working.The affected device was reinstalled and tested multiple times; however, the issue could not be resolved.The malfunction occurred during the procedure.The procedure was completed using a new device, resulting in a small delay.No harm to the patient was reported.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,b5,d9,g3,g6,h2,h3,h6,h11.Corrected section: h6-device code changed to 2170.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,b5,d9,g3,g6,h2,h3,h6,h11.Corrected section: d4-udi#; h6-patient code changed to 4582; device code changed to 2170.The lot # 3000435738 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.
Event or Problem Description
The hospital reported that the suction function of the acrobat-i stabilizer was not working.The affected device was reinstalled and tested multiple times; however, the issue could not be resolved.The malfunction occurred during the procedure.The procedure was completed using a new device, resulting in a small delay.No harm to the patient was reported.

• Brand Name: ACROBAT-I STABILIZER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 23703961
• Report Number: 2242352-2025-0001274
• Device Sequence Number: 10649948
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: (01)00607567700581(10)3000435738(17)270127
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

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 Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000435738
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/08/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG