Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling without duplicating the report.The device was recertified and returned to the customer.Without the clinical log, we are unable to provide an explanation as to why the device recommended a shock that the user thought was a non-shockable rhythm.No trend is associated with reports of this type.
|