Model Number R SERIES |
Device Problem
Reset Problem (3019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
|
|
Event Description
|
Complainant alleged that during a routine shift check by a clinician, the device restart/reboot itself multiple times.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The device was evaluated by a zoll approved service provider.The customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.It was determined that the device worked as expected.The device was recertified and returned to the customer.Review of the device activity logs did not show any activity for the event date.No trend is associated with reports of this type.
|
|
Search Alerts/Recalls
|