Model Number 297300000000 |
Device Problems
Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.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 1 malfunction event, where it was reported the device experienced exposed bare wires.There was no patient involvement.
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Manufacturer Narrative
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Upon inspection of the final device, it was determined the device experienced cosmetic damage, which is not reportable.
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Event Description
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This report summarizes 1 malfunction event, where it was reported the device experienced exposed bare wires.There was no patient involvement.
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Search Alerts/Recalls
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