Model Number X 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 (b)(4) service department, instead a data file was provided for review.The customer's report was observed during review of the data file.Review of the data file indicated the multifunction cable gasket fretting.The customer was advised to order a replacement defib cable receptacle and multifunction cable as a precaution.Analysis for reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|