Model Number G5A-80A |
Device Problems
High impedance (1291); Unable to Obtain Readings (1516)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
|
|
Event Description
|
Complainant alleged that during functional testing, the device failed for high impedance and did not detect the attached electrode pads.Complainant did not indicate that there was any patient involvement in the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation evaluated the device and the device performed to specification.A review of the device log indicates the customer did not have electrode pads attached, which prompted the device to record the reported errors.The device was recertified and returned to the customer.It is important to note that the customer's report of "the device failed for high impedance" was inadvertently submitted.Reports of this nature have no potential for clinical impact.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|