MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-20 for SYMBIS T, SYMBIA S 08717733 manufactured by Siemens Medical Solutions Usa, Inc..
[2337811]
The following product problem was found. There are no customer complaint reports. Analyzer peak error in acquisition electronics board firmware version 1. 5. 9. 12 is exhibiting an error in the window position after the analyzer is peaked. For iodine 131, the off shift is in the order of -6%. This means that the acquired counts in an i131 image may not demonstrate the isotope distribution as expected and may impact image interpretation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2011-00003 |
| MDR Report Key | 2317563 |
| Report Source | 07 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-06 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2011-09-26 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-07-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA RBIO, MGR. |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8652182534 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1423253-10/11/2011-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIS T, SYMBIA S |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2011-10-20 |
| Model Number | 08717733 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-20 |