Model Number ORT200 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Preliminary investigation on-site through a third-party representative indicates the malfunction is attributed to the actuator component within the rotational locking mechanism.The manufacturer of the operating room table is working to further investigate the malfunction and collect the actuator component for analysis.
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Event Description
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It was reported that during a quality assurance/functional check, the ort200 rotational locking mechanism would not lock the table position into place.No patient was involved at the time.
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Manufacturer Narrative
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Investigation of similar events by the supplier of the actuator component has identified reported malfunctions due to a switch within the actuator component.The manufacturer of the operating room table has initiated internal corrective action to further address this issue.Based on event details and isolation of the functional issue at the customer site to the actuator component, this event is within scope of the internal corrective action.
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Search Alerts/Recalls
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