Between January 1, 2000 and December 31, 2013 BfArM received a total of 61,904 reports regarding medical devices. Of these 57,356, 28,715, 28,641, and 4,548 reports were related to medical devices in total (both, active and non-active), active medical devices, non-active medical devices, and IVD, respectively. Out of the 61,904 reports, 50,053 were received within the study period of January 1, 2005 and December 31, 2013, from which 45,938, 23,394, 22,544, and 4,115 were related to medical devices in total (both, active and non-active), active medical devices, non-active medical devices, and IVD, respectively. Comparison of the notifications reported to the BfArM in the years 2000, 2005, and 2013 underlines a strong increment of reports to this Competent Authority (3,387 in 2005 vs. 1,934 in 2000: +75.1 %, 8,252 in 2013 vs. 1,934 in 2000: +326.7 %, and 8,252 in 2013 vs. 3,387 in 2005: +143.6 %). A total of 6,465 FSCA were publicized since January 1, 2005 of which 4,912 were related to active and non-active medical devices and 1,553 to IVD, which also demonstrates a strong increase (1,077 in 2013 vs. 483 in 2005: +123.0 %) within the observation period (Table 2). Based on the inclusion criteria, only FSCA related to medical devices for use in pulmonology were analyzed in the present study. These were 41 FSCA mostly for active medical devices (6 nebulizers, 7 oxygen concentrators, 15 pulse oximeters, 4 lung function analyzers, and 9 devices serving for pleural drainage, treatment of lung emphysema, or bronchial stenosis).

German and English FSN were found in 36 and 35 cases, respectively (nebulizers 6/4, oxygen concentrators 5/6, pulse oximeters 15/13, lung function analyzers 2/3, and devices for pulmonary treatment 8/9) (Table 3). FSN were clearly characterized as such in 22/20 cases and names of the affected products were provided in 36/35 cases. Lot numbers were provided in 7/8 cases and other attributions for product identification was available in 26/24 cases, respectively. Detailed information regarding the FSCA and product malfunction was found in 27/33 and 36/35 cases, respectively. Product malfunction was due most frequently to a fault in construction and production of the product or an issue with the raw material and components of the product in 27/27 cases. Examples of these were issues in the power supply (mains adapter or battery, 5/5 cases), issues with overheating resulting in an increased fire hazard (5/5), and issues of sensor components (4/4 cases), likely as these components seem to be a fragile and sensitive part of the affected systems. In 3/2 cases a product deficiency could be excluded and the FSCA was made due to a revision of the standard specifications, preventive revision of instructions for use to implement further safety recognitions and preventive expansion of warning notices and protective measures in the instructions for use and in 1/1 case the manufacturer informed customers about product counterfeiting. A software error or an erroneous installation of software was reported in 2/2 cases and an invalid alerting was also reported in 2/2 cases of German and English FSN, respectively. In 1/1 case, a specific description of the product malfunction was impossible because the root-cause analysis was not finished at the time of the FSN.