Catalog Number 8065990794 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device history record (dhr) for the device and bed has been reviewed.The associated device was released based on company acceptance criteria.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported during refractive ablation the bed moves anywhere from.5 to 2 millimeters making the apex of the laser off in the z-axis.The issue appears to be weight related in patients over 150 pounds.The surgeon reports that he has to place his hand under the headrest during procedures although this causes his gloves to become unsterile.
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Manufacturer Narrative
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The device history record (dhr) for the device and bed has been reviewed.The associated device was released based on company acceptance criteria.During the onsite visit, the fse (field service engineer) replaced headrest, z motor, joystick and completed system verification as per sir (service installation record).Without sample no deeper root cause analysis is possible.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Control panel with joystick and headrest received.These parts are not related to complaint.Z- motor received.The reported issue is a known issue.Non conformance investigations were opened to address reported issues.The root cause was identified as patient bed mechanics.The z-motor was improved to prevent further issues.The root cause was identified as patient bed mechanics.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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