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

Model Number	XP-5000
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure, acrobat-i positioner, they said that when they were installing the acrobat-i positioner on platform and lock lever locker is at lock position but is not working functional.The angle of acrobat-i swivel should provide 180 degree side-to-side range of motion of the arm and 90 degree vertical drop and suction cup should fixed when opening vacuum pressure but in some of angle it stuck and can not fix for the particular angle.So they decided to replace it with a new one immediately without using on the patient.There is no procedural delay.There was no harm due to the potential harm product.
Additional Manufacturer Narrative
Trackwise id (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
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 08/10/2023.An investigation was conducted on 08/15/2023.A visual inspection was conducted.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 knob of the device was turned to tighten the flexarm link with no visual of physical difficulties observed.A suction/vacuum strength test was performed per instructions of the vacuum leak test (mcv00001178 rev.A), using calibrated vacuum weight tlt (id: (b)(6); 2 lbs; due 31-mar-2024) and calibrated pressure gauge (id: (b)(6); due 30-apr-2024).The device passed the vacuum leak test, good vacuum was obtained and the baffle head was able to lift the weight.Based on the returned condition of the device and the results of the investigation the reported failure "suction problem " was not confirmed.The lot # 3000289882 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17644875
• Report Number: 2242352-2023-00668
• Device Sequence Number: 8059670
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: 00607567700574
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (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): 09/15/2023

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: 01/15/2025
• Device Model Number: XP-5000
• Device Catalogue Number: XP-5000
• Device Lot Number: 3000289882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown