Model Number ACROBAT-I STABILIZER |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer z arm was stiffer than usual and the movement was slow, so the new item was opened and the operation was continued and completed without any problem.There was no health hazard to the patient.
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Event Description
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N/a.
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Manufacturer Narrative
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(b)(4).The lot # 3000190117 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.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.
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Search Alerts/Recalls
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