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

Model Number	OM-10000Z
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported went the patient was in the or before the procedure, when opening the box with acrobat-i stabilizer it was found that the blade was missing.No injury or harm to the patient.A new device was opened to complete the case.No delays were reported.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Tw#: (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The investigation has been started since the complaint was received, the following contents have been conducted: 1.Device historical record 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% visual inspection and function test during production.They all passed the inspection and function test which demonstrate the part assembly is integrated.2.Trend review: in the 12 months from 19-oct 2024 to 18-jun 2025 (date of event), the occurrence rate for the reported issue is found to be (b)(4) for acrobat-i c-om-10000/z/s, which is under anticipated occurrence rate.3.The device was returned to wayne factory for evaluation on nov.03, 2025, and wayne factory provided the photos of the returned device.A visual inspection was conducted by wayne factory.The box was opened and the tray for the blades was not observed in the returned product box.The manufacture processes were reviewed and no deficiency indicating the reported failure was observed, which demonstrated the production process are normal and all devices were packaged correctly.Since the whole tray is missing and no using details is available for review, the specific root cause is impossible to define.The ifu has the warnings and precautions that ¿do not use if the product sterilization barrier or its packaging is compromised.¿ and the device missing could be identified by customer before using, there was no patient involved, 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.Reason for close: the investigation has been conducted.Mdr has been completed.The complaint file is completed.Comments: the device was returned to wayne factory for evaluation and wayne factory provided the photos of the returned device.The box was opened and the tray for the blades was not observed in the returned product box.The manufacture processes were reviewed and no deficiency indicating the reported failure was observed, which demonstrated the production process are normal and all devices were packaged correctly.Since the whole tray is missing and no using details is available for review, the specific root cause is impossible to define.The occurrence rate is about (b)(4), which is under the anticipated o=1 (< 0.1%), the risk is considered as low.Ifu also has the warnings and precautions that ¿do not use if the product sterilization barrier or its packaging is compromised.¿ and the device missing could be identified by customer before using, there was no patient involved, and no consequences or impacts to the patient.There were no ncrs, rework, or deviations documented for the reported batch.The trending will be monitored continuously.
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 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: 23529117
• Report Number: 2242352-2025-0001188
• Device Sequence Number: 9047565
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: (01)00607567100008(10)3000423188(17)260924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Expiration Date: 09/24/2026
• Device Model Number: OM-10000Z
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000423188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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 Sex: Unknown