Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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During investigation of the monitor for an unrelated issue, a reportable malfunction was found.The monitors front response button was difficult to activate.The cause for the failure was caused by the front response button was crushed making it difficult for the response button to be pushed.The root cause of the off damaged dome cannot be positively identified.No adverse event resulted from the damaged monitor.
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Event Description
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During investigation of the monitor for an unrelated issue, a reportable malfunction was found.The monitors response buttons were difficult to activate.
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Search Alerts/Recalls
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