MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-09-30 for BUCKY DIAGNOST CS2 MRD5492 NA manufactured by Philips Systeme Medezin.
[137332]
Reportedly, the x-ray tube cover detached from the cs2 x-ray tube ceiling suspension. Allegedly the cover fell, striking the technologist in the face near her eye and nose. Reportedly, the technologist was x-rayed for a possible fractured nose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1999-00021 |
| MDR Report Key | 243456 |
| Report Source | 05,06 |
| Date Received | 1999-09-30 |
| Date of Report | 1999-09-03 |
| Date of Event | 1999-09-03 |
| Date Facility Aware | 1999-09-03 |
| Report Date | 1999-09-03 |
| Date Reported to Mfgr | 1999-09-03 |
| Date Mfgr Received | 1999-09-03 |
| Date Added to Maude | 1999-10-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRANK GIANELLI |
| Manufacturer Street | PO BOX 860 710 BRIDGEPORT AVE |
| Manufacturer City | SHELTON CT 064840917 |
| Manufacturer Country | US |
| Manufacturer Postal | 064840917 |
| Manufacturer Phone | 2039267729 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUCKY DIAGNOST CS2 |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 1999-09-30 |
| Model Number | MRD5492 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 235865 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | BUCKY DIAGNOST CS 2 |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Baseline Model No | MRD5492 |
| Baseline Catalog No | NA |
| Baseline ID | 9848-500-23202 |
| Baseline Device Family | BUCKY DIAGNOST CS 2/4 FAMILY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-09-30 |