Catalog Number 521200380100 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.
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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.10 devices were not evaluated, as the issue was identified and resolved through communication/interviews with the user facility.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Manufacturer Narrative
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The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated to reflect this.
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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.
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Search Alerts/Recalls
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