Catalog Number 0607687000 |
Device Problems
Device Inoperable (1663); Noise, Audible (3273)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 05/07/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure the handle of the autoplex was found to be very stiff and that the device was making a loud noise while turning, which caused a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported that during a procedure, the handle of the autoplex was found to be very stiff and that the device was making a loud noise while turning, which caused a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The reported condition can be considered confirmed based on evaluation of the returned product.The injector handle presented some resistance and noise when rotated.The device was discarded by the manufacturer.
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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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Search Alerts/Recalls
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