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

Model Number	XP-5000Z
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw # (b)(4) the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during the procedure, the xp-5000z suction on positioner wasn't sucking as it should.The positioning device and the suction cup would not seal on the heart.Stabilizer was hooked up to constant suction, no problems with second piece of equipment.A new device was used to complete the procedure.Slight intraoperative delay to connect new device.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Trackwise #(b)(4).Updated sections: b4, g4, g7, h2, h3, h6, h10.Corrected sections: d10b-return to manufacture date; h10-health effect ¿ impact codes (2).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.Trend review: in the last 12 months, the occurrence rate is 0.008% which is under anticipated occurrence rate.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 the suction cup can lift the weight as required in manufacture working instruction (mp-bh-0022), 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.
Event or Problem Description
N/a.

• 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: 21351645
• Report Number: 2242352-2025-0000135
• Device Sequence Number: 15412965
• Product Code: MWS
• UDI-Device Identifier: 00607567500006
• UDI-Public: (01)00607567500006(10)3000441118(17)261207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• 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 Model Number: XP-5000Z
• Device Catalogue Number: XP-5000Z
• Device Lot Number: 3000441118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG