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 received the product and will be providing a supplemental report when our investigation is completed.
|
|
Event Description
|
Complainant alleged that during biomed testing, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The reported malfunction was duplicated and attributed to the top ecg shield on the analog board.The device was rectified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|