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

Model Number	OM-10000
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id#(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 during a coronary artery bypass procedure, acrobat-i stabilizer surgeon was not able to tighten the stabilizer knob.It kept rotating and didn't get tight.Procedure completed with a new device.There were no procedural delays and patient was not harmed.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10.No ship history is available for the account.Should a lot number become available, the complaint will be reopened and added.H3 other text : device not returned.
Event or Problem Description
N/a.

• Brand Name: ACROBAT-I STABILIZER
• 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: 18608747
• Report Number: 2242352-2024-00068
• Device Sequence Number: 11468365
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: 00607567700581
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: OM-10000
• Device Catalogue Number: OM-10000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 60 YR
• Patient Sex: Male