Model Number 945-605 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Burn(s) (1757); Burn, Thermal (2530)
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Event Date 01/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Associated manufacturers report - 3002807968-2019-00002.
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Event Description
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According to the complaint received, a patient sensor burn from a tcpo2 sensor used with a tcm400 monitor was reported.A (b)(6) year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.
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Event Description
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A 48 year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area of where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.According to the complaint received, a patient sensor burn from a tcm400 monitor was reported.A 48 year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied.On (b)(6) 2019 the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area of where the sensor was placed.The patient was admitted to the wound care center where the wound currently is being treated.
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Manufacturer Narrative
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The affected electrode was tested in a monitor and calibrated, hereafter it measured correctly.The tc-electrode will be sent to production for additional testing.
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Search Alerts/Recalls
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