Model Number E SERIES |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
|
|
Event Description
|
Complainant alleged that while attempting to pace a male patient (age unknown) the device was set to 70ppm and the patient's heart rhythm did not change.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
The device was returned and the reported malfunction was not replicated or confirmed.The device was put through extensive testing, which included environmental and functional testing without duplicating the malfunction.The device was attached to a simulator and the pacing functionality was tested with no faults found.The device was recertified and returned to the customer.No trend is associated with reports of this type.
|
|
Search Alerts/Recalls
|