Model Number 8001 |
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 06/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that the devices failed the electrical testing which has the potential to cause ac shock.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
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Manufacturer Narrative
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Upon further investigation of the reported event, it was discovered that the issue was likely due to user error.
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Event Description
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It was reported that the devices failed the electrical testing which has the potential to cause ac shock.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
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Search Alerts/Recalls
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