BERCHTOLD GMBH & CO. KG EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-; DEVICE, MEDICAL EXAMINATION, AC POWERED
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Catalog Number CE 2863075 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.The investigation is ongoing.Once the investigation is complete, a supplemental will be filed.There was no injury or adverse consequence reported.
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Event Description
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It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.There was no injury or adverse consequence reported.
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Manufacturer Narrative
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It was reported that a bulb burned out on an f300 exam light.The light then disengaged at the horizontal arm to spring arm joint, potentially due to a warped or displaced locking ring (also referred to as a c-clip).The light was repaired and functionality verified.There was no associated procedure and no surgical delay.While it is unknown how the locking ring became warped and/or displaced, this issue could have occurred during installation or during system maintenance.There was no injury or adverse consequence reported.
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Event Description
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It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.There was no injury or adverse consequence reported.
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Search Alerts/Recalls
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