Model Number 902-778 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Burn(s) (1757)
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Event Date 05/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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Please note that the incident date stated is best estimation.Furthermore, please also note catalog number is best estimation as this information is not known in the complaint.Unfortunately also the serial number, udi number and manufacturing date of the device is still unknown.The information will be added in a follow-up mdr when known.
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Event Description
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A customer reported bruising and redness on both legs bilaterally where the tcm sites were placed on an elgan (extremely low gestational ages newborn) (b)(6) weeks old newborn.The doctor felt the skin was so concerning and ordered for a wound consultant.
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Manufacturer Narrative
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It was informed by the radiometer representative that the hospital is using sensor 54 (item number: 945-736 manufactured by radiometer basel ag) with fixation ring 32 mm (item number: 5601500 manufactures by radiometer basel ag) in combination with the tcm combim monitor.More information has been asked from radiometer to the customer for the further investigation.
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Manufacturer Narrative
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It is not possible to conclude on an investigation based on the available information in this case.The operator's manual describes that the smaller n20 fixation or adhesive ring should be used for neonates.The smaller ring may be more gentle to the skin due to the smaller adhesive surface.It was recommended to the customer to try this smaller ring instead of the 32mm ring for this patient population.The customer has informed that they will continue to use the larger fixation rings, despite radiometer's recommendation.
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Search Alerts/Recalls
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