Catalog Number G16808 |
Device Problems
Flaked (1246); Material Fragmentation (1261); Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation was started.A follow-up report will be sent as soon as the investigation is closed.
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Event Description
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A pendula device in operation room of the (b)(6) hospital has problems with paint letting loose.The pendula was in use during the event.No injury reported.
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Manufacturer Narrative
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The investigation was based on the affected pendula arms.The arms were replaced with new ones at the customer site and were sent to the manufacturer for analysis.It was found that due to a missing primer during the production process, the very smooth metal surface of the pendula was not properly prepared for the afterwards applied varnish.In the consequence it was possible that the applied varnish flakes from the flange.The failure in the production process have been corrected.According to the supplier, no further arms sold by dräger are affected by this failure.This is assessed to be a single occurrence.
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Event Description
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Please refer to the initial-report.
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Search Alerts/Recalls
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