Problem report

A problem report does not have to lead to a change, but each one has to be investigated and evaluated for its effect on safety. For released software, IEC 62304 also asks whether a regulatory action, such as a report or a field action, is needed.

a record of actual or potential behaviour of a MEDICAL DEVICE SOFTWARE that a user or other interested person believes to be unsafe, inappropriate for the intended use or contrary to specification NOTE 1 This standard does not require that every PROBLEM REPORT results in a change to the MEDICAL DEVICE SOFTWARE. A MANUFACTURER can reject a PROBLEM REPORT as a misunderstanding, error or insignificant event. NOTE 2 A PROBLEM REPORT can relate to a released MEDICAL DEVICE SOFTWARE or to a MEDICAL DEVICE SOFTWARE that is still under development. NOTE 3 This standard requires the MANUFACTURER to perform extra decision making steps (see Clause 6) for a PROBLEM REPORT relating to a released product to ensure that regulatory actions are identified and implemented.

IEC 62304:2006+AMD1:2015, clause 3.13