Model Number R SERIES |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
|
|
Event Description
|
Complainant alleged that during functional testing, the device displayed "pacer disabled" and "pacer fault 115" messages.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty relay on the pace/defib engine board.A replacement device was sent to the customer.Analysis for reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|