Catalog Number SW5-HOSE-7 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
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Event Type
Injury
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Manufacturer Narrative
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Report source: (b)(6).
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Event Description
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Information was received indicating that a smiths medical level 1® equator® convective warming device burned a patient.There were no reported further adverse effects.
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Manufacturer Narrative
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Additional information was received indicating that second degree and third degree burns were noted to the patient's toes following use of a level 1® equator® convective warming hose.The patient was reported to have been lying flat on his back during the procedure.Jelonet dressings and flammazine cream were used for the treatment of the burns.Prolonged sedation and immobilization with extended hospital stay was reported.There was no further reported adverse effects.
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Manufacturer Narrative
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One level 1® equator® convective warming device was returned for investigation.The device was slightly dirty but in good condition.The hose (#sw5-hose-7) was damaged.The power cord (#6051008) was not the original one.When tested however the values were found to be acceptable.The device passed the initial self-test.The investigator then selected for different temperatures.The device initially worked as intended.The hose sensor cable was then manipulated to see if the product problem could be replicated.No issues were identified.The device passed all the functional tests.No fault was found with the device.
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Event Description
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Device analysis completed and updated.
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Search Alerts/Recalls
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