Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation of electrode belt has been completed.The reported problem (add gel / replace belt messages) has been confirmed.Upon investigation the electrode belt failed a therapy electrode recognition test.The cause for the failure was isolated to broken wires connecting the distribution node (dn) and rear therapy electrode causing the "add gel messages".The root cause for the broken wires was excessive force.No adverse event resulted from the damaged belt.
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Event Description
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A us distributor contacted zoll to report that a patient was experiencing "add gel/replace belt" messages.
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Search Alerts/Recalls
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