Model Number X SERIES |
Device Problem
Failure of Device to Self-Test (2937)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Complainant alleged that during biomed testing, the device failed self-test for defib function.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical australia.The customer's report was verified and the processor/bridge/pace board was replaced to remedy the report.The device was recertified and returned to the customer.The suspect processor/bridge/pace board was returned to zoll chelmsford.Our evaluation attributed the report to the processor/bridge/pace board.However, the testing was unable to verify cause to the component level.The board was scrapped at zoll.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|