Catalog Number MA3320-PM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
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Event Date 04/05/2017 |
Event Type
Injury
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Event Description
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It was alleged that a patient was undergoing cardioversion therapy while using the air blanket and received burns.The patient allegedly received 1st and possibly 2nd degree burns around both electrodes that were being used during the cardioversion therapy.One electrode was placed on the sternum and one electrode was placed on the spine.It was reported that there was no medical intervention needed and no lasting adverse effects for the patient.
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Manufacturer Narrative
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It was reported that the patient was burned during this therapy due to the blanket conducting electricity from the defibrillator.To address this issue a label will be added to the point of use (individual blanket packaging) and the ifu to indicate the correct orientation of the blanket on the patient and a warning to not cover the patient's torso during defibrillation.
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Event Description
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It was alleged that a patient was undergoing cardioversion therapy while using the air blanket and received burns.The patient allegedly received 1st and possibly 2nd degree burns around both electrodes that were being used during the cardioversion therapy.One electrode was placed on the sternum and one electrode was placed on the spine.It was reported that there was no medical intervention needed and no lasting adverse effects for the patient.
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Search Alerts/Recalls
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