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

Model Number	ACROBAT-I POSITIONER
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
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
The hospital reported that during a coronary artery bypass procedure the acrobat-i positioner was not able to tighten the position.They had to open another one to complete the case.The faulty unit will return.No injury to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, d4, g4, g7, h2, h3, h4, h6, h10 ,h11.Corrected section: d4- udi number -corrected.The device was returned to the factory for evaluation on 08/04/2022.An investigation was conducted on 08/15/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the device.A mechanical evaluation was conducted.The device was attached to a reference blade with no physical or visual difficulties observed.The knob was tightened to position of the arm of the device.The arm locked into place.Based on the returned condition of the device as well as the evaluation results, the reported failure "positioning problem" was not confirmed.The lot 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: 15214943
• Report Number: 2242352-2022-00692
• Device Sequence Number: 14955866
• Product Code: MWS
• UDI-Device Identifier: 00607567500006
• UDI-Public: 00607567500006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 09/29/2023
• Device Model Number: ACROBAT-I POSITIONER
• Device Catalogue Number: XP-5000
• Device Lot Number: 3000195663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown