Catalog Number 6252000000 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2020 |
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.The devices were evaluated in the field and the issue was confirmed; 1 device had a broken/damaged component, and 7 devices had missing 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 8 malfunction events, where it was reported there was inadequate patient restraint.There was no patient involvement.
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Search Alerts/Recalls
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