MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-16 for * 4X4 PANEL manufactured by Carr Corp..
[15034305]
Employee was shocked when turning on the viewbox. Upon inspection of this device, it appears this device had a mfg defect that caused a "hot" wire from one of ballasts to be pinched by an internal star washer and case screw. Two distinct "scorch" marks were noted in the interior of the viewbox, evidence of an electrical arc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015230 |
| MDR Report Key | 201928 |
| Date Received | 1998-12-16 |
| Date of Report | 1998-12-09 |
| Date of Event | 1998-09-14 |
| Date Added to Maude | 1998-12-17 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | * |
| Generic Name | 4X4 PANEL VIEWBOX |
| Product Code | IXC |
| Date Received | 1998-12-16 |
| Model Number | 4X4 PANEL |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 40"X57" |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 196135 |
| Manufacturer | CARR CORP. |
| Manufacturer Address | 1547 - 11TH STREET SANTA MONICA CA 90401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-16 |