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

Model Number	XP-5000Z
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(6).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
Related to 745360.The hospital reported that during a coronary artery bypass procedure acrobat-i positioner wouldn't lock into place when moving it to the back of the heart.The malfunction happened twice in the same case.A new box was opened to complete the procedure.No injury to the patient.
Additional Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation on 01/06/2023.An investigation was conducted on 01/11/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.A mechanical evaluation was conducted.The positioner was attached and locked onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The flexlink arm was able to be adjusted and positioned, and then locked into place by turning the knob clockwise with no physical or visual difficulties, with the locking lever in both the locked and unlocked positions.Based on the returned condition of the device as well as the evaluation results, the reported failure ¿mechanical problem" was not confirmed.The lot # 3000226531 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: 16237640
• Report Number: 2242352-2023-00055
• Device Sequence Number: 6523107
• Product Code: MWS
• UDI-Device Identifier: 00607567500006
• UDI-Public: 00607567500006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 03/07/2024
• Device Model Number: XP-5000Z
• Device Catalogue Number: XP-5000Z
• Device Lot Number: 3000226531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male