FDA 483 - Zoll Medical Corporation - June 13, 2022

ZOLL Medical Corporation in Deerfield, WI, received a Form FDA 483 with five observations, two of which were repeat observations from a 2016 inspection. The observations primarily concern significant deficiencies in the firm's quality system, particularly regarding corrective and preventive actions, complaint handling, medical device reporting, and risk management for their Class III Powerheart G5 AED, which has a critical error code 501 linked to patient death. The firm also failed to adequately approve purchasing data for a critical device component.