Catalog Number 6252000000 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
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 a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 6 devices had missing components and 1 device had a broken/damaged component.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 7 malfunction events, where it was reported there were inadequate patient restraints.There was no patient involvement.
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Search Alerts/Recalls
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