Events

Avis De Sécurité sur Fine Pressure Regulator

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-07-23
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    The fine pressure regulator is connected to a central air supply that is part of the hospital installation and has two connectors, both to power an air driven power tool and to inflate a tourniquet. by applying excessive force, the hose of the tourniquet could be mistakenly connected to the connector for the air driven power tools, thus resulting in excess pressure and the explosion of the tourniquet.

Device

Fine Pressure Regulator
  • Modèle / numéro de série
    2067; 2152; 2237; 2245; 2250; 2253; 2256; 2034; 645-1708-9602; 1805; 2078; 2090; 2282; 2021; 2035; 2102; 2130; 2210; 2239; 2243; 2280; 2285; 1301; 1303; 1633; 1783; 2033; 2062; 2065; 2067; 2076; 2080; 2129; 2150; 2089; 2091; 2216; 2236; 2248; 2249; 2255; 2258; 2262; 2264; 2265; 2266; 2269; 2037; 2084; 2092; 2093; 2096; 2098; 2099; 2104; 2105; 2107; 2109; 2110; 2122; 2124; 2125; Fine Pressure Regulator, 520 890 2126; 2127; 2128; 2132; 2238; 2240; 2242; 2247; complete ' 2251; 2252; 2257; 2260; 2261; 2267; 2284; 2289; 2296; 2298; 2301; 2302; 201; 2013; 2271; 9999; 2100; 2101; 2103; 2108; 2145; 2146; 2147; 2148; 2209; 2211; 2212; 2213; 2215; 2217; 2223; 2225; 2226; 2227; 2229; 2230; 2231; 2233; 2234; 2235; 2131; 2268; 2066; 1250; 2017; 2018; 2019; 2063; 2088; 2095; 2151; 2202; 2259; 2270; 2275; 2277; 2283; 2286; 2290; 2297; 2299; 2303; 2304; 2201; 2036; 2241; 2246
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH