MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-12 for * BFO-150 manufactured by Chiu Technical Corp.
[601895]
Newborn recently transferred to nicu from the birth hospital, was found to have blistering along the side of the right leg after the drapes were removed following picc line placement. A transilluminator had been used to facilitate vein location. The device was tested by our biomed dept and it appeared to be working correctly but it was noted that the box part got very hot if covered by a blanket or towel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 837228 |
| MDR Report Key | 837228 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-12 |
| Date of Event | 2005-01-29 |
| Report Date | 2007-04-12 |
| Date Reported to FDA | 2007-04-12 |
| Date Added to Maude | 2007-04-16 |
| 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 | 0 |
| 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 | * |
| Generic Name | LIGHT SOURCE |
| Product Code | HJM |
| Date Received | 2007-04-12 |
| Model Number | BFO-150 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 824534 |
| Manufacturer | CHIU TECHNICAL CORP |
| Manufacturer Address | 252 INDIAN HEAD ROAD KINGS PARK NY 11754 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-12 |