Catalog Number 50004 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/19/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Load not recalled.
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Event Description
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A customer reported a screen freeze issue with their evotech ecr and it is unknown if the load was reprocessed prior to being released for use on a patient(s).Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined that this situation presents a potential risk of infection.Asp recognizes that in many cases it would be difficult to trace infection back to the sterilization or high level disinfection.As a matter of policy asp has therefore decided to report cases of cancelled cycles if the complainant does not confirm that the load was reprocessed prior to use on a patient.
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Manufacturer Narrative
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Advanced sterilization products (asp) received additional information from the customer stating that the load involved was reprocessed with the cycle cancellation issue.As a result, this complaint is deemed not reportable for unknown load status.
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Search Alerts/Recalls
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