Model Number MSERIES BI-PHASIC |
Device Problem
Output Problem (3005)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling and extensive pacer functionality testing without duplicating the report.An internal inspection of the device and inspection of the multi-function cable found no issues.The device was recertified and returned to the customer.No trend is associated with reports of this type.
|
|
Event Description
|
Complainant alleged that during biomed testing, the device's pacer output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Search Alerts/Recalls
|