Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Communication or Transmission Problem (2896)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/13/2023 |
Event Type
malfunction
|
Event Description
|
A us distributor reported that an electrode belt was unable to communicate with the monitor.
|
|
Manufacturer Narrative
|
Device evaluation of electrode belt has been completed.The reported problem (does not communicate with monitor) has been confirmed.Upon investigation the electrode belt failed a therapy electrode recognition test.The cause for the failure was isolated to a cut pulse wire in the cable connecting the distribution node (dn) and trunk cable.The root cause for the cut wire was excessive force.There was no adverse event that resulted from the damaged belt.
|
|
Search Alerts/Recalls
|