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

Model Number	OM-10000Z
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 before the procedure, the om-10000z could not be fixed even by turning the knob, so they stopped using it.A new device was used.There was no harm or effect on the patient.There was no procedural delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw (b)(4).Updated field: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Dhr of the reported batch is reviewed, there¿s no deficiency identified from production relevant to the knob difficult/ unable to tighten-arm does not lock issue prior to this complaint.All the products had been performed 100% mechanical function test during production.They all passed the function test, which demonstrates the knob can be tightened and also can tighten the link arm.The reported lot was manufactured starting from oct.25th, 2024, lot qty was (b)(4).There's no ncr relevant with ¿knob tighten link arm¿ initiated during the manufacturing process.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,g3,g6,h2,h11.Corrected section: d4 udi#, lot#, exp date; h4-mfg date.On oct.16, 2025, fse(field service engineer) confirmed that the device had been disposed of within the hospital and could not be returned due to infectious problem.Therefore, the device could not be evaluated, and it is impossible to confirm the reported complaint.Dhr of the reported batch is reviewed, there¿s no deficiency identified from production relevant to the knob difficult/ unable to tighten-arm does not lock issue prior to this complaint.All the products had been performed 100% mechanical function test during production.They all passed the function test, which demonstrates the knob can be tightened and also can tighten the link arm.The reported lot was manufactured starting from sept.04th, 2024, lot qty was 448ea.There's no ncr relevant with ¿knob tighten link arm¿ initiated during the manufacturing process.
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: 23115726
• Report Number: 2242352-2025-0001063
• Device Sequence Number: 9298364
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: (01)00607567100008(10)3000418471(17)260904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2025

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: 09/04/2026
• Device Model Number: OM-10000Z
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000418471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 12/19/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/31/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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