Model Number X SERIES |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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 while attempting to pace a patient (age & gender unknown), the device was unable to pace.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device with multi-function cable was put through extensive testing including bench handling, ecg testing and pacer testing without duplicating the report.The device side panel was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
|
|
Search Alerts/Recalls
|