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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER; STABILIZER, HEART Back to Search Results
Model Number OM-10000Z
Device Problems Positioning Failure (1158); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2023
Event Type  malfunction  
Manufacturer Narrative
Trackwise 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 Description
The hospital reported that during preparation, the acrobat-i stabilizer had looseness of fixed parts (fixing part of the arm is loose).A replacement device was used to complete the procedure.No procedural delay.No harm to patient.
 
Manufacturer Narrative
Trackwise #(b)(4).Corrected section: h6-medical device ¿ problem code- corrected to "1158".The device was returned to the factory for evaluation on 07/19/2023.An investigation was conducted on 08/01/2023.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 positioner was attached and locked onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The flexlink arm was able to be adjusted and positioned, and then locked into place by turning the knob clockwise with no physical or visual difficulties, with the locking lever in both the locked and unlocked positions.Based on the returned condition of the device as well as the evaluation results, the reported failure ¿positioning problem" was not confirmed.The lot # 3000288696 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.
 
Event Description
N/a.
 
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Brand Name
ACROBAT-I STABILIZER
Type of Device
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 Key17325904
MDR Text Key319129897
Report Number2242352-2023-00592
Device Sequence Number1
Product Code MWS
UDI-Device Identifier00607567100008
UDI-Public00607567100008
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/11/2023
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 NumberOM-10000Z
Device Catalogue NumberOM-10000Z
Device Lot Number3000288696
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2023
Initial Date FDA Received07/14/2023
Supplement Dates Manufacturer Received08/11/2023
Supplement Dates FDA Received08/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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