Catalog Number 6252000000 |
Device Problem
Device Fell (4014)
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Patient Problems
Muscle Weakness (1967); No Patient Involvement (2645)
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Event Date 04/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is part of the fda voluntary malfunction summary reporting program.1 device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.2 devices were evaluated in the field and the issue was confirmed; the devices had broken/damaged components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 3 malfunction events, where it was reported the device dropped/collapsed.There was 1 event where the user experienced muscle weakness.
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Search Alerts/Recalls
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