MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-01-19 for SCOPO 76 4512-129-06371 NA manufactured by Philips Medical Systems.
[416473]
A bariatric pt was undergoing fluoroscopy examination. After 56 seconds of fluoroscopy, the examination technique was changed because of poor quality to digital spot films. After a total of 39 digital spot films were completed, the cathode ray tube exploded spraying the pt, x-ray tech and physician with oil. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2006-00002 |
| MDR Report Key | 666574 |
| Report Source | 00 |
| Date Received | 2006-01-19 |
| Date of Report | 2006-01-19 |
| Date of Event | 2005-04-11 |
| Report Date | 2006-01-19 |
| Date Mfgr Received | 2005-04-13 |
| Device Manufacturer Date | 1991-10-01 |
| Date Added to Maude | 2006-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOPO 76 |
| Generic Name | SPOT FILM DEVICE |
| Product Code | IXL |
| Date Received | 2006-01-19 |
| Model Number | 4512-129-06371 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 632122 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | SCOPO 76 |
| Baseline Generic Name | SPOT FILM DEVICE |
| Baseline Model No | 4512-129-06371 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K924593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-19 |