Model Number R SERIES |
Device Problem
Output Problem (3005)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Complainant alleged that during biomed testing, the device's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
|
|
Manufacturer Narrative
|
Zoll medical corporation evaluated the device and the device performed to specification.The customer's report was not observed during evaluation of the device.The device was recertified and returned to the customer.Review of the device log observed a total of 28 shock events.The user tested the device from 5j to 200j.The output recorded in the log is within the device specification per the r series operator's guide.The device worked as expected.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|