The U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database includes several reports from within the last year that describe similar events.
Gambro is aware that the Prismaflex touchscreen interface may become unresponsive and believes that the problem occurs when clinicians press softkeys in very rapid succession, such as when navigating quickly through alarm screens. The company indicates that it has received no reports of injury related to the problem and believes that it does not present a safety risk. Nonetheless, Gambro indicates that it has addressed (or plans to address) the issue in software revisions.
Gambro states that outside the United States, the baseline software version (4.10) is not affected by the problem. Within the United States, the company anticipates addressing the issue with the release of version 5.10, which will replace the version currently in use (3.2) and will be available free of charge. Gambro expects FDA 510(k) clearance for version 5.10 in the near future.
Source: ECRI Institute
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ReplyDeleteI was infected with HSV 2 for the past two years and i was unable to get a better job cos all the company i was to get employed checked our blood test and found out that i was positive to GENITAL HERPES and i loosed employment.
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i earlier made some research and i contacted some doctors online but they keep on asking for money for courier after that they'll tell you that tax and so more so i became broke and frustrated.
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so i decided to thank Neme Amber cos she made it possible for me.
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my Name is Grace from US,once again thanks to Neme Amber. im fucking hapy....