Model Number R SERIES |
Device Problems
Grounding Malfunction (1271); Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Complainant alleged that during biomed testing, the device failed leakage current test.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
|
The device was returned to zoll medical corporation for evaluation.The customer's report was observed and attributed to a faulty nibp pump.The nibp pump was replaced to resolve the report.The device was returned to the customer.Reports of this nature are not considered to meet our requirements for the submission of a medwatch report due to no potential for clinical impact.Analysis of reports of this type has not identified an increase in trend.
|
|
Event Description
|
Complainant alleged that during biomed testing, the device failed nibp leak testing.Complainant indicated that there was no patient involvement in the reported malfunction.
|
|
Search Alerts/Recalls
|