MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-15 for E.COM, SYMBIA E 04380213 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[2573163]
The following product problems was found. There are no injury reports received. For e. Cam and symbia e systems that have had either the motor assembly or motor replaced, the possibility exists that the radial drive shaft gear may have been replaced incorrectly. The detector must be positioned above/obliquely around the pt without clearance to remove the pt by pulling the pts out when a failure occurs. Removing the pt prevents injury. The probability is limited to those systems that have had the motor assembly or motor replaced in the field and that when the replacement occurred, the svc engineer replaced the radial drive shaft gear backwards. Systems that have not had the radial drive shaft gear replaced in the field are not affected. The radial drive shaft gear assembly is correct in mfg.
Patient Sequence No: 1, Text Type: D, B5
[9720130]
Affected model numbers: 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745. There are three (3) applicable 510 (k): e. Cam: k992731, symbia e single/dual: k0782506, k082506.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2012-00001 |
| MDR Report Key | 2511533 |
| Report Source | 07 |
| Date Received | 2012-03-15 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-02-23 |
| Date Added to Maude | 2012-08-29 |
| 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 | LAURA MEYER |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8473046022 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E.COM, SYMBIA E |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2012-03-15 |
| Model Number | 04380213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-15 |