Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Defibrillation/Stimulation Problem (1573)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/20/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluation of monitor has been completed.The reported problem (delivers pulse below lower limit) was isolated to the insulated-gate bipolar transistor (igbts) q13 on the defibrillator pca board being shorted.The root cause for the shorted components was unable to be positively identified.There was no adverse event that resulted from the damaged monitor.
|
|
Event Description
|
A us distributor returned a monitor and reported monitor delivered a pulse below the lower limit.
|
|
Search Alerts/Recalls
|