MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-02 for PUCK FILM CHANGER 93 59 159 G127E BA manufactured by Siemens Medical Systems, Inc..
[18719]
While pt was having an angiography procedure, one of two mounting brackets for the film changer was noted to be broken. The film changer was tilted. The pt was removed from the table. The second bracket then broke causing the film changer to fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009011 |
| MDR Report Key | 32525 |
| Date Received | 1996-05-02 |
| Date of Report | 1996-04-24 |
| Date of Event | 1996-03-05 |
| Date Added to Maude | 1996-05-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PUCK FILM CHANGER |
| Generic Name | FILM CHANGER |
| Product Code | KPX |
| Date Received | 1996-05-02 |
| Model Number | 93 59 159 G127E |
| Catalog Number | BA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 33805 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | DANVERS MA 01923 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-02 |