FDA Hits Siemens Medical with Form 483
The FDA handed Siemens Medical Solutions USA a Form 483 for failing to report device malfunctions that could present health risks on at least four occasions between 2011 and 2014.
The investigator cited an incident in December 2011 when a patient was prepped for a transesophageal echocardiogram but was unable to undergo the procedure because of malfunction. The company’s health risk evaluation indicated the software malfunction could cause an unstable patient to be sedated longer in the operating room, classified the software patch as a Class III recall, but didn’t notify the FDA district recall coordinator or open a corrective and preventative action report.
According to the March 27 Form 483 following an FDA inspection starting on March 16, the company failed to adequately establish procedures for CAPA or to adequately document those activities. Additionally, not all complaints had been adequately evaluated to determine if an investigation was necessary and staff training procedures were not adequately established.
Siemens received the Form 483 and is carefully reviewing it to understand and respond appropriately to the agency’s observations, a company spokeswoman said.
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