Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Siemens Medical Solutions USA, Inc. ACUSON Juniper and ACUSON Maple Ultrasound systems [HKMD No.: 230475].
According to the MHRA, the system incorrectly performs a unit conversion of liters to milliliters using a multiplier of 100 (one hundred) instead of using the correct multiplier of 1000 (one thousand) in specific situations. The result of this conversion error is the presentation of a 10x under-estimated measured value. This unit conversion issue displays an inaccurate value that is 10x smaller than the actual measurement ONLY after a system is changed from the factory default configuration units of measure to display the following:
If undetected and used in isolation, volume flow measurement values that are under-represented by a factor of 10 could contribute to misdiagnosis of a patient's condition or influence patient management decisions in a negative way. The potential risk of misdiagnosing a severe condition from an under-represented volume flow measurement is unlikely as a volume flow measurement is only one of several independently measured parameters. Also, the Doppler imaging and other adjunctive diagnostics would conflict with an erroneous volume flow measurement.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/PSTKKDNTZFWNRq8g
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Aug 2024