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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. MAQUET; STABILIZER, HEART

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MAQUET (SUZHOU) CO.,LTD. MAQUET; STABILIZER, HEART Back to Search Results
Model Number ACROBAT-I STABILIZER
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2023
Event Type  malfunction  
Manufacturer Narrative
Trackwise #: (b)(4).The investigation has been started since the complaint was received, the following contents have been conducted: dhr review: the dhr of the reported lot 3000294462 has been reviewed.No non-conformity relevant with the reported issue is observed.All the products had been performed 100% mechanical function test during production.They all passed the function test which demonstrate the knob can be tightened and can also tighten the flexlink arm.Trend review: 28th jun 2022 to 28th jun 2023, the occurrence rate is approx.0.080% for suzhou manufactured om-10000/om-10000z which is under anticipated rate.Returned device evaluation: the device was received on jul.24th 2023, the following evaluations have been conducted: visual inspection: no visual defects were observed on the device; functional test: rotating the knob in clockwise, idling rotating was found, the knob cannot be tightened and flexlink arm cannot be tightened.To check this knob idling rotating during tightening, the stabilizer was disassembled for checking the relevant assembly and components status.Disassemble and examine the assembly according to the applicable manufacturing process instructions, it is found that the lead-in thread on acme nut was broken.Verify 2 to 4 threads of the acme screw are exposed past the housing mount.It shows about 3 threads out of the housing mount, the returned product is conforming to this requirement.Check the pilot crimping and its position, the pilot crimping is conforming to process instruction requests.Replace the abnormal acme nut with a new one taken from another raw material lot to check the function of the returned product.It¿s not found knob tighten issue, the knob rotating smoothly without idling, and the flexlink arm can be tightened.The component dimension was checked, which is conforming to the drawing requirements, no deficiency was observed.Based upon the above evaluation, there¿s no deficiency identified from production relevant to the mechanical issue-knob difficult/ unable to tighten-arm does not lock prior to this complaint.It is not indicated that it is the product problem, and also not indicates a manufacturing defect caused or contributed to the reported failure during the investigation.Complaint historical data has also been reviewed, the failure ¿knob difficult/ unable to tighten-arm does not lock" happened before and has been investigated.The most probable root cause for the acme nut lead in thread broken would be rotating to loosen the knob anti-clockwise rapidly for several circles and then rotating to tighten the knob clockwise rapidly, or rotating the knob leaner or too much strength used, which caused acme screw misaligned with the acme nut lead-in thread, acme nut lead-in thread broken, then the knob could not be tightened and flexlink arm could not be tightened.
 
Event Description
On (b)(6), 2023, the hospital reported that in a case of coronary artery bypass surgery, when the stabilization system was installed, the operator found that the knob could not be tightened, after replacing with a new product, it was used normally and the operation was completed.The product is from lot 3000294462.
 
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Brand Name
MAQUET
Type of Device
STABILIZER, HEART
Manufacturer (Section D)
MAQUET (SUZHOU) CO.,LTD.
no.158 fang zhou road
suzhou industrial park
suzhou
Manufacturer (Section G)
MAQUET (SUZHOU) CO.,LTD.
no.158 fang zhou road
suzhou industrial park
suzhou
Manufacturer Contact
lu helena
no.158 fang zhou road
suzhou industrial park
suzhou 
MDR Report Key17421812
MDR Text Key320088937
Report Number3007417753-2023-00003
Device Sequence Number1
Product Code MWS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/31/2023
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
Device Operator Health Professional
Device Model NumberACROBAT-I STABILIZER
Device Catalogue NumberOM-10000
Device Lot Number3000294462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2023
Initial Date Manufacturer Received 07/15/2023
Initial Date FDA Received07/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
Patient SexMale
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