Catalog Number 0206500000 |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Hearing Loss (1882); No Consequences Or Impact To Patient (2199)
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Event Date 01/03/2019 |
Event Type
malfunction
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Event Description
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It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.However, it was further reported at the time that a nurse was being evaluated for a potential hearing injury.Additional information has been requested from the user facility.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.It was initially reported that a nurse standing next to the tank needed to be evaluated for potential hearing injuries but it was later confirmed that no follow up care was needed and there were no adverse consequences to report.
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Search Alerts/Recalls
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