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

Model Number	XP-5000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the acrobat-i positioner handle would not tighten.A new device was opened and used to complete the case without issue.No harm to the patient.
Additional Manufacturer Narrative
(b)(4).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.Initial reporter exceeds character limitations: (b)(6).
Event or Problem Description
The hospital reported that the acrobat-i positioner handle would not tighten.A new device was opened and used to complete the case without issue.No dealy.No harm to the patient.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, b5, d9, g3, g6, h2, h3, h6, h11.Corrected sections: d4.The device was returned to the factory for evaluation on 02/05/2026.An investigation was conducted on 02/17/2026.Signs of clinical use and evidence of blood was observed on the device.There were no visual defects observed on the device.A mechanical evaluation was conducted.The device was able to be locked on a reference retractor with no physical or visual difficulties observed.The knob of the device was turned to tighten the flexarm link.The flexarm link did tighten.Based on the returned condition of the device and the results of the investigation the reported failure "mechanical problem " was not confirmed.The lot # 3000500354 - 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.

• Brand Name: ACROBAT-I POSITIONER
• 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: 24256544
• Report Number: 2242352-2026-0000044
• Device Sequence Number: 8346382
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: (01)00607567700574(10)3000500354(17)270904
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: XP-5000
• Device Catalogue Number: XP-5000
• Device Lot Number: 3000500354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: NO CONCOMITANT PRODUCTS WERE USED.
• Patient Sex: Unknown