MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-25 for SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4 manufactured by Siemens.
[17070957]
Siemens delaying or refusing to supply aiat info per 21cfr 1020. 30 and 1020. 33 for the siemens volume -access- zoom, sensation plus 4, somatom emotion, somatom esprit, somatom balance, spc
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007811 |
| MDR Report Key | 1083252 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-25 |
| Date of Event | 2008-07-25 |
| Date Added to Maude | 2008-08-04 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4 |
| Generic Name | SIEMENS VOLUME ACCESS ZOOM, SENSATION PLUS 4 |
| Product Code | IYX |
| Date Received | 2008-07-25 |
| Model Number | SIEMENS VOLUME |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1049851 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-25 |