Model Number E-SERIES |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A steris surgical services specialist arrived onsite to inspect the harmonyair e-series surgical lighting system and confirmed the dual monitor yoke had detached.The dual monitor yoke associated with this event was returned to the steris montgomery facility and has been submitted for engineering evaluation.The technician replaced the dual monitor yoke, tested the lighting system, confirmed it to be operating according to specification, and the lighting system was returned to service.A follow-up mdr will be submitted should additional information become available.
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Event Description
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The user facility reported that during a patient procedure one of the dual monitor yokes to their harmonyair e-series surgical lighting system separated from the spring arm and was hanging by the lighting system cables.User facility personnel stabilized the monitors on a stand resulting in a procedure delay.The procedure was completed successfully.No report of injury.
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Manufacturer Narrative
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The results of the evaluation of the returned device concluded that the cause of the reported yoke detachment could not be determined.The unit is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities, steris will continue to monitor for similar events.
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Search Alerts/Recalls
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