Model Number WCD 4000 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/25/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluation of monitor sn (b)(4) has been completed.Upon investigation the monitor was unable to communicate with an electrode belt.The monitor's electrode belt connector was broken free from the monitor enclosure, partially unplugging connector j1001 from the ca board.The root cause for the damaged connector was excessive force.No adverse event resulted from the defective monitor.
|
|
Event Description
|
During an investigation of a monitor for an unrelated issue, a reportable malfunction was found.The monitor failed incoming functional testing and was unable to communicate with an electrode belt.
|
|
Search Alerts/Recalls
|