MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-25 for HICOR DIGITAL SYSTEM 1024 manufactured by Siemens Medical Systems, Inc..
[20761819]
Film magazine hung on system. When tightening film, film magazine released and fell, hitting the pt on the forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003178 |
| MDR Report Key | 15517 |
| Date Received | 1994-08-25 |
| Date of Report | 1994-08-17 |
| Date of Event | 1994-06-02 |
| Date Added to Maude | 1994-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HICOR DIGITAL SYSTEM |
| Generic Name | FILM MAGAZINE |
| Product Code | IXA |
| Date Received | 1994-08-25 |
| Model Number | 1024 |
| ID Number | 111998 - COROSKOP HS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 15510 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-25 |