Model Number X SERIES |
Device Problem
Incorrect Interpretation of Signal (1543)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
|
|
Manufacturer Narrative
|
The suspect device was not returned to zoll medical corporation for evaluation.However, the clinical file of the customer's report was provided.A review of the clinical file shows the device operated as intended as two of the three segments analyzed did not meet the criteria for a shockable event.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|