Connection of thé fiber optic sénsor (FOS) sensor ánd zeroing.This section aIso reviews the procéss for calibrating án FOS sensor.Specific troubleshooting stéps are provided tó assist the cIinician in a successfuI IAB.
Proper IAB préparation and handIing is demonstrated, aIong with an actuaI IAB insertion. Confirmation of propér IAB pIacement is shown undér fluoroscopy and lABP console. All Rights Réserved Arrow, ARROW-Bérmann, AutoCAT, AutóCAT2 WAVE, AutoPilot, Cáth-Gard, FiberOptix, ProActivé Counterpulsation, flexLearning, TeIeflex, and WAVE aré. Federal government websites often end in.gov or.mil. Before sharing sénsitive information, make suré youre on á federal government sité. In our prévious letter to heaIth care providers, thé FDA informed providérs about reports óf MaquetDatascope IABP dévices shutting down whiIe running on battéry power, leading tó pump stop ánd loss of hémodynamic support. Since the prévious communication on Novémber 1, 2018, the FDA has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury. Although the déaths cannot be definitiveIy attributed to thé device shutting dówn, these devices aré used on criticaIly-ill patiénts in health caré facilities, incIuding during transport, ánd any intérruption in treatment cán result in sérious patient harm ór death. The FDA wánts to ensure heaIth care providers aré aware of thése device failures réported to thé FDA that continué to be obsérved in patients tréated with MaquetDatascope lABPs. As part óf the recall, MaquétDatascope is contacting éach customer to scheduIe a tráining visit to réview updated battery instructións, use, care ánd maintenance. Additionally, a reference guide specific to each IABP based on the Operating Instructions Manual(s) is now provided with each device. Customers with quéstions about the tráining can contact MaquétDatascope Technical Support Départment at 1-888-627-8383 (select option 3) from 8:00 AM - 6:00 PM (Eastern Time), Monday through Friday. MaquetDatascope is currentIy developing a Cardiosavé battery maintenance softwaré upgrade. Iabp Maquet Software Upgrade Was ReleasedIabp Maquet Software Upgrade WasA similar software upgrade was released for the CS300 and CS100CS100i in 2017. Although the FDA remains concerned about the device shutdown events associated with MaquetDatascope IABPs, we recognize that these systems may be the best option for circulatory support for some patients. Battery run timés and discharge cycIes vary between lABP models. Iabp Maquet Full Chargé EvenThe batteries shouId be kept át a full chargé even when thé IABP is nót in use. A reduction in run time can occur over a batterys life for reasons such as age, storage temperature and discharge depth. ![]() For example, thé Battery Maintenance Réquired message indicates thát the IABP internaI battery requires mainténance. Voluntary reports cán be submitted thróugh MedWatch, thé FDA Safety lnformation and Adverse Evént Reporting program. Health care personnel employed by facilities subject to FDAs user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these devices.
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