Events

Field Safety Notices about Fine Pressure Regulator

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-07-23
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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