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MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-25 for ASTODIA * manufactured by Stihler Electronic, Gmbh.

These parts are Bepco parts and are not manufactured by the Original Equipment Manufacturer (OEM). Original Manufacturers' names, parts numbers and descriptions are quoted for reference purposes only and are not intended to indicate or suggest that our replacement parts are made by the OEM.

[3257320] Attempted to start a peripheral iv on an infant using the stihler electronic astodia light to visualize the veins. Less than one minute after turning on the light and having it against the infant's skin the light became hot. Removed it and the light had left what appeared to be a first degree burn approximately 1. 5cm x 1cm. The neonatal np notified and a skin consult initiated. Follow-up information received that the infant had blister and open skin. Wound consult showed partial thickness burn to bottom of foot. Per unit, device had to be kept in a certain position to stay on. Per biomed, some intermittent short in the cable, but it was a unit brought in for evaluation so could not be examined/repaired by biomedical. Cable was taped to the case and unit was used by staff. What was the original intended procedure? Iv start. Patient Sequence No: 1, Text Type: D, B5