The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a device alert regarding counterfeit Covidien Nellcor SpO2 Durasensor (DS-100A), which may have been supplied to hospitals and clinics.
According to MHRA, the legitimate manufacturer Covidien found that sample counterfeit devices had partially failed to provide SpO2 readings when tested with OxiMax/Nellcor monitors.
MHRA has recommended the individuals who use or maintain these devices to identify and isolate any suspect devices, and contact the local Covidien representative to authenticate them.
Nellcor SpO2 Durasensor (DS-100A) sensors are indicated for use with pulse oximeters for non-invasive measurement of oxygen saturation of patients over 40kg.