MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-15 for CS 2 9890-010-06521 NA manufactured by Philips Systeme Medezin.
[205004]
Reportedly, the cover detached from the cs2 x-ray tube ceiling suspension and allegedly the cover fell striking the technologist on the top of the head. Reportedly, the technologist was examined in the hosp emergency room and she was found not be injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1999-00024 |
| MDR Report Key | 251274 |
| Report Source | 05,06 |
| Date Received | 1999-11-15 |
| Date of Report | 1999-10-25 |
| Date of Event | 1999-10-24 |
| Date Facility Aware | 1999-10-24 |
| Report Date | 1999-10-25 |
| Date Reported to Mfgr | 1999-10-25 |
| Date Mfgr Received | 1999-10-25 |
| Date Added to Maude | 1999-11-29 |
| 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 | CS 2 |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 1999-11-15 |
| Model Number | 9890-010-06521 |
| 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 | 243429 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | CS 2/4 |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Baseline Model No | 9890-010-06521 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | BUCKY DIAGNOST CS 2/4 FAMILY |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K945278 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-15 |