Catalog Number 4115000000 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/21/2014 |
Event Type
malfunction
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Event Description
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It was reported that the battery was observed to be broken and some liquid came out.There was no patient involvement, and there were no user injuries or adverse consequences.Attempts to obtain additional information were made, but were not successful.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Event Description
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It was reported that the battery was observed to be broken and some liquid came out.There was no patient involvement, and there were no user injuries or adverse consequences.Attempts to obtain additional information were made, but were not successful.
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Manufacturer Narrative
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The reported event, leaking, was confirmed; a dried rust residue was found.Upon disassembly, the technician also found internal corrosion.Based on a review of the risk documents and observations from the device inspection, the presence of internal corrosion is caused by improper sterilization.The device was scrapped by the manufacturer.
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Search Alerts/Recalls
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