Model Number R SERIES |
Device Problem
Sparking (2595)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/20/2018 |
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 cardiovert a patient (age & gender unknown), a spark was seen from the associated electrodes causing a red mark on the patient's skin.Complainant indicated that the burn was not severe, the skin was pink around the pad as well as under the pad and the patient did not require any medical intervention.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the device logs indicate the patient's impedance was 76.7 ohms, while the defib's impedance was 125.0 ohms.This is an indication that there was poor coupling between the patient and pads, which can lead to the reported malfunction.The associated electrode pads were not available for evaluation.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|