MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-18 for SIRESKOP 4 NA manufactured by Siemens Medical Systems, Inc..
[17825279]
During gi radiology procedure, spot film device gantry almost fell onto pt. Md caught gantry before it hit pt. Pt examined, no injury found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001712 |
| MDR Report Key | 51503 |
| Date Received | 1996-11-18 |
| Date of Report | 1996-10-29 |
| Date of Event | 1996-10-16 |
| Date Added to Maude | 1996-11-27 |
| 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 | SIRESKOP 4 |
| Generic Name | SPOT-FILM DEVICE |
| Product Code | IXL |
| Date Received | 1996-11-18 |
| Model Number | SIRESKOP 4 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52173 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 186 WOOD AVE S. ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-18 |