Model Number ORT300 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2022 |
Event Type
malfunction
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Event Description
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The customer reported that during their morning quality assurance / functional check, the ort300 rotational locking mechanism would not lock the table position into place.No patient was involved at the time; the customer reported an upcoming case planned for the operating room in which the issue occurred was moved into the adjacent operating room.
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Manufacturer Narrative
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An imris service engineer went on-site the following day 2022-11-02 to assess the operating room table and attempted to lock the table's rotational position into place through the handheld pendant.The engineer was unable to lock the table's rotational position in place, confirming the reported issue.The engineer traced the cause to an actuator component within the rotational locking mechanism, and removed and replaced the actuator component.The table was functionally tested after actuator component replacement and confirmed to function as intended.The actuator is returning to the manufacturer for further investigation.
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Manufacturer Narrative
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The actuator component was returned to the manufacturer and assessed by the component supplier, who confirmed the reported malfunction due to a switch within the actuator.Internal corrective action has been initiated to further address this issue.
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Search Alerts/Recalls
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