MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-09 for DERMOPAN-1 SYSTEM 01438605 NA manufactured by Siemens Med Solutions Usa, Inc..
[2627659]
Siemens (b)(4) was notified via the (b)(4) on (b)(4) 2012, that a pt radiation overdose occurred on (b)(6) 2012. The initial report received was that a possible malfunction had occurred due to a combination of incorrect filter settings, causing an overdose of treatment to a pt. The pt was notified of the overdose and will be medically observed. Siemens service personnel inspected the unit and identified a broken switch, and also confirmed that the device in question is a dermopan-1. Reportedly, the customer has permanently removed the device from service and operation.
Patient Sequence No: 1, Text Type: D, B5
[9676522]
Siemens (b)(4) became aware of the reported issue on (b)(4) 2012 and this mdr is being mailed on march 8, 2012. Siemens discontinued sale and no longer manufactures or distributes the dermopan systems. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2012-00016 |
| MDR Report Key | 2490043 |
| Report Source | 01,07 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-02-09 |
| Date of Event | 2012-02-02 |
| Date Mfgr Received | 2012-02-09 |
| Date Added to Maude | 2012-03-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLYNNE GALLOWAY |
| Manufacturer Street | 51 VALLEY STREAM PKWY, D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6102195361 |
| Manufacturer G1 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Street | 4040 NELSON AVE. RADIATION ONCOLOGY |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMOPAN-1 SYSTEM |
| Generic Name | X-RAY RADIATION THERAPY SYSTEM |
| Product Code | JAD |
| Date Received | 2012-03-09 |
| Model Number | 01438605 |
| Catalog Number | NA |
| Lot Number | NA |
| 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 MED SOLUTIONS USA, INC. |
| Manufacturer Address | 4040 NELSON AVE RADIATION ONCOLOGY CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-09 |