MAUDE Adverse Event Report: Maquet Cardiovascular LLC Acrobat-i Stabilizer; Stabilizer, Heart

Model Number	OM-10000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during midcab acrobat-i stabilizer locking knob was not turning on first use so it was immediately replaced.No patient harm.
Additional Manufacturer Narrative
Tw (b)(4).Event site name exceeds character limitations: (b)(6) center.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.

• 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: 50865373
• Report Number: 2242352-2026-0000826
• Device Sequence Number: 13106347
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: (01)00607567700581(10)3000569096(17)280614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/23/2026

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: 3000569096
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 06/15/2026
• 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 Sex: Unknown