Model Number X SERIES |
Device Problem
Failure of Device to Self-Test (2937)
|
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 failed self test for pacer function.Complainant did not indicate that there was any patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The reported malfunction was observed during review of the device history logs.However, the reported problem could not be duplicated with the device.The processor/bridge/pace board was replaced as a precauton.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
|