MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-15 for SIREMOBIL COMPACT * manufactured by Siemens Medical Solutions Usa, Inc..
[938323]
Equipment failure during surgery c-arm malfunctioned. Unable to get a clear image of sinuses. Delayed and altered the surgery - sinuplasty. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1188744 |
| MDR Report Key | 1188744 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-09-15 |
| Date of Event | 2008-06-25 |
| Report Date | 2008-09-15 |
| Date Reported to FDA | 2008-09-15 |
| Date Added to Maude | 2008-10-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIREMOBIL COMPACT |
| Generic Name | C-ARM, PORTABLE |
| Product Code | IZO |
| Date Received | 2008-09-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1222499 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-15 |