MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-07-25 for BUCKY DIAGNOST CS 2 9890 001 06521 NA manufactured by Philips Systeme Medezin.
[67656]
Reportedly, the cover of the x-ray tube ceiling suspension fell and allegedly struck the x-ray technologist's head. The technologist reportedly had a large bump on top of the head and felt dizzy. She was taken to er and reportedly she has severe post neck pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1997-00025 |
| MDR Report Key | 108584 |
| Report Source | 05,06 |
| Date Received | 1997-07-25 |
| Date of Report | 1997-06-27 |
| Date of Event | 1997-06-27 |
| Date Facility Aware | 1997-06-27 |
| Report Date | 1997-06-27 |
| Date Reported to Mfgr | 1997-06-27 |
| Date Mfgr Received | 1997-06-27 |
| Date Added to Maude | 1997-07-30 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUCKY DIAGNOST CS 2 |
| Generic Name | X-RAY TUBE CEILING SUSPENSION |
| Product Code | ITY |
| Date Received | 1997-07-25 |
| Model Number | 9890 001 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 | 106719 |
| Manufacturer | PHILIPS SYSTEME MEDEZIN |
| Manufacturer Address | * HAMBURG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-25 |