Model Number 70103.5075 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2015 |
Event Type
malfunction
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Event Description
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It was reported that customer stated belt slip alarm.No consequences to the patient.(b)(4).
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Manufacturer Narrative
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Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary is aware of similar complaints from this product.Similar products, showing similar malfunction have tested.A supplemental medwatch will be submitted after receiving new information.
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Manufacturer Narrative
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Maquet cardiopulmonary is aware of similar complaints from this product.Similar products, showing similar malfunction, have tested.Customer stated the twin pump would display a belt slip message on screen prior to use.Service was called and evaluated the twin pump.Ran system at low and high rounds per minute with test tubing pack and no message or belt slip was displayed.Tested system to factory specifications.Tested ok.Thus failure cannot be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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