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.
[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
| Report Number | 3026796 |
| MDR Report Key | 3026796 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-03-21 |
| Report Date | 2013-03-25 |
| Date Reported to FDA | 2013-03-25 |
| Date Reported to Mfgr | 2013-03-29 |
| Date Added to Maude | 2013-03-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTODIA |
| Generic Name | TRANSILLUMINATOR |
| Product Code | HJN |
| Date Received | 2013-03-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIHLER ELECTRONIC, GMBH |
| Manufacturer Address | JULIUS-HOLDER-STRASSE 36 STUTTGART, GERMANY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-03-25 |