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Model Number BT-350 |
Device Problem
False Reading From Device Non-Compliance (1228)
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Patient Problem
Burn, Thermal (2530)
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Event Date 01/04/2018 |
Event Type
Injury
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Event Description
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Fetal monitors/cardiotocogram machines of manufacturer: bistos co., ltd model bt-350 with fda no.(b)(4) were installed with central monitoring system at (b)(6) hospital (b)(6) on (b)(6) 2017.User reported of burns at mother site where toco sensors were placed on (b)(6) 2017.The event was reported to manufacturer and few toco sensors were replaced.On (b)(6) 2018 more events of burns were reported with us and toco sensors, also the user reported for false readings of fhr in machines even without placing the us sensor at actual fetus location.Manufacturer was reported of these events and no resolution is made till date.Further use of machines is suspended due to life threatening issues concerned with fetus because machines are giving false readings that may be considered as actual observing on central monitor and could not alert the user department for any distress or emergency situation of fetus that may lead to uterine death.
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Search Alerts/Recalls
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