MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-12-17 for CS 4 9890-010-06521 NA manufactured by Philips Systeme Medezin.
[20922956]
Reportedly, during an exam, the cover detached from the cs4 x-ray tube ceiling suspension and allegedly the cover fell striking the radiology technologist on the head. Reportedly, prior to the cover falling, the x-ray tube suspension was being moved and it collided with an articulated surgical lamp arm. The technologist was examined and she was found to have a cervical spine strain. She received physical therapy once a day for one week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1999-00025 |
| MDR Report Key | 256558 |
| Report Source | 05 |
| Date Received | 1999-12-17 |
| Date of Report | 1999-11-30 |
| Date of Event | 1999-11-30 |
| Date Facility Aware | 1999-11-30 |
| Report Date | 1999-11-30 |
| Date Reported to Mfgr | 1999-12-07 |
| Date Mfgr Received | 1999-12-07 |
| Date Added to Maude | 1999-12-29 |
| 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 | 710 BRIDGEPORT AVE PO BOX 860 |
| Manufacturer City | SHELTON CT 064840917 |
| Manufacturer Country | US |
| Manufacturer Postal | 064840917 |
| Manufacturer Phone | 2039267729 |
| Manufacturer G1 | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS 4 |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 1999-12-17 |
| 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 | 248440 |
| 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 | 1. Other | 1999-12-17 |