|
Model Number 8900-4005 |
Device Problems
Sparking (2595); Noise, Audible (3273); Patient Device Interaction Problem (4001)
|
Patient Problem
Burn(s) (1757)
|
Event Date 12/21/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Event Description
|
Complainant alleged that while attempting to cardiovert a 66-year-old male patient, a spark was seen from the electrode pads and a loud pop noise was heard.After removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The customer was unable to provide information on the degree of the burn.Please reference medwatch report numbers 1218058-2022-00069 and 1218058-2022-00070 for similar reports from the same customer.Complainant indicated electrode lot numbers 1921 and 4021b were involved in these three patient events, however, they did not specify which lot was used with each specific patient.
|
|
Manufacturer Narrative
|
The actual electrode pads were not returned to zoll medical corporation for evaluation.Instead, 2 lot numbers of the pads was provided.An investigation was conducted on retained samples of pro*padz solid gel radiolucent multi-function electrodes, lot 4021b and 1921 for the customer's report.The retained samples were subjected to full functional testing with passing results.A visual inspection found the lot assembly built according to specification.Review of all records were performed and passed.Based on the evaluation of the retained samples it was concluded that the samples were assembled according to specification without duplicating the report.Burns during cardioversion are not an unexpected outcome and can result from multiple reasons including, but not limited to; how the skin is prepared, skin condition of the patient, how the electrodes are applied, and poor coupling.Improper skin preparation or pad placement may result in incomplete contact with the skin and air pockets, which can contribute to the situation as reported by the customer.Analysis of reports of this type has not identified an increase in trend.
|
|
Search Alerts/Recalls
|
|
|