Model Number X SERIES |
Device Problem
Mechanics Altered (2984)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Complainant alleged that during a routine shift check by a clinician, the device powered up in the incorrect mode.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical singapore.The customer's report was observed during testing.However, the reported problem could not be duplicated.The configuration was imported as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|