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 a routine shift check by a clinician, the device displayed a "check pads" message.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical corporation for evaluation and the customer's report was not duplicated under testing.The device was put through extensive testing which included bench handling and performing multiple self-tests without duplicating the malfunction.Review of the device activity log does show occurrences of the reported error message.The analog board was replaced as a precaution.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
|