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

Model Number	OM-9000Z
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw # (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.
Event or Problem Description
The hospital reported that after the thoracotomy, they attempted to secure the acrobat suv vacuum stabilizer system (om-9000z) feet to the affected area, but the suction was too weak to secure the feet, so they unpacked a new kit.A replacement device was used to complete the procedure.There was no major delay.There was no adverse effect on the patient's health.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise #(b)(4).The investigation has been started since the complaint was received, the following contents have been conducted: 1.Dhr review: the dhr of the reported lot has been reviewed.No non-conformity relevant with the reported issue is observed.All the products had been performed 100% function test during production.They all passed the function test which demonstrate the suction works normally.2.(b)(4).3.The device was received and evaluated for a visual inspection, signs of clinical use and evidence of blood were observed on the device.There were no visual defects observed on the device.The suction function of the returned device was evaluated by connecting the device to the test system following label instructions, the test result indicated malleable stabilizer foot can lift the weight as required in manufacture working instruction (mp-bh-0049), suction works normally.Based on the returned condition of the device as well as the evaluation results, the reported failure ¿suction weak¿ was not confirmed.There were no ncmrs, rework, or deviations documented for the reported batch, based on above review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: ACROBAT SUV STABILIZER SYSTEM
• 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: 21377187
• Report Number: 2242352-2025-0000151
• Device Sequence Number: 3826344
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: (01)00607567900004(10)3000412741(17)260802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 08/02/2026
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000412741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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