BERCHTOLD CORP EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-
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Catalog Number CE 2863075 |
Device Problem
Disconnection (1171)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the f300 light would not power on.The light was visually inspected by a stryker field service technician who reported a small separation at the upper suspension arm.A stryker quality engineer initiated a review of the manufacturing history.The evaluation is ongoing and a supplemental will be submitted upon completion.There was no patient involvement, no injury and no adverse consequence reported.
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Event Description
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It was reported that the f300 light would not power on.There was no patient involvement, no injury and no adverse consequence reported.
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Manufacturer Narrative
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It was reported that the f300 exam light would not power on.When stryker field service technician (sfst) visited the site, he noted that the snap ring had slipped and was no longer making connection with the upper suspension arm electrical connection.He re-seated the snap ring into the slot and inspected for correct seating.This resolved the issue and the light could be powered on.The light did not fall and there was not visible separation in the unit.There were no adverse consequences or patient involvement.This exam light was installed in march 2015.There are no records of service by stryker following installation.The f300 operating manual (57363 rev h) outlines that general maintenance should be performed by berchtold (stryker) annually.It was confirmed by the sfst that all equipment in this facility is serviced by an in-house biomed department.It is believed that someone at the site improperly serviced the equipment.If the snap ring was mis-seated at installation, it is likely that the site would have seen a failure sooner than 16 months after installation.The snap ring was properly seated by the sfst and the issue was resolved.
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Event Description
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It was reported that the f300 light would not power on.There was no patient involvement, no injury and no adverse consequence reported.
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Search Alerts/Recalls
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