MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-09 for COOL SPOT 0134522 * manufactured by Burton Medical Products.
[217094]
Two occasions where burton exam light arm/light head assemblies separated from the down tube and fell. The first fell and struck an incubator with a pt on board in the nicu. The second, also in the nicu, broke while being positioned by a staff member. The light was caught by the staff member, but was left hanging by the electrical wiring until engineering arrived to remove the device. No pt harm occurred in either event. Burton has replaced all arm assemblies at no charge to the hosp, but hosp feel it prudent to report these events because of concern for safety and quality mfg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023048 |
| MDR Report Key | 355377 |
| Date Received | 2001-10-09 |
| Date of Report | 2001-10-09 |
| Date Added to Maude | 2001-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL SPOT |
| Generic Name | LIGHTS, EXAMINATION |
| Product Code | FCQ |
| Date Received | 2001-10-09 |
| Model Number | 0134522 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 344599 |
| Manufacturer | BURTON MEDICAL PRODUCTS |
| Manufacturer Address | 21100 LASSEN ST CHATSWORTH CA 91311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-09 |