Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Event Description
|
Complainant alleged that during biomed testing, the device displayed an "ecg disabled" message.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The device was not returned to zoll medical corporation.Instead, the customer removed and returned the suspect analog board.Testing of the analog board in a test unit subjected to multiple testing including full functionality testing without duplicating the report.The analog board was scrapped as a precaution.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|