MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-02-07 for EASYDIAGNOST RSF748AT NA manufactured by Philips Medical Systems O..
[440504]
A x-ray procedure was in progress when the attending x-ray technician turned around and walked into the x-ray monitor hitting their head. The technician fell into unconsciousness with a gash to the forehead requiring three stitches.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1217116-2006-00004 |
MDR Report Key | 674187 |
Report Source | 05 |
Date Received | 2006-02-07 |
Date of Report | 2006-02-06 |
Date of Event | 2006-01-10 |
Report Date | 2006-02-06 |
Date Mfgr Received | 2006-01-10 |
Device Manufacturer Date | 2002-03-01 |
Date Added to Maude | 2006-02-15 |
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 | EASYDIAGNOST |
Generic Name | FLUOROSCOPIC X-RAY SYSTEM |
Product Code | IXL |
Date Received | 2006-02-07 |
Model Number | RSF748AT |
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 | 663467 |
Manufacturer | PHILIPS MEDICAL SYSTEMS O. |
Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
Baseline Brand Name | EASYDIAGNOST |
Baseline Generic Name | FLUOROSCOPIC X-RAY SYSTEM |
Baseline Model No | RSF748AT |
Baseline Catalog No | NA |
Baseline ID | NA |
Baseline Device Family | EASYDIAGNOST |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K970640 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2006-02-07 |