MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-11-30 for SIEMENS BRAND NAME: 550 TXT TABLE 7346534 manufactured by Siemens Medical Solutions Usa, Inc..
[1257123]
A potential product issue has been reported with our oncor impression plus linear accelerator with the 550 txt table. In the abundance of caution this issue is being reported. A defective 24v power supply caused in the 550 txt table smouldering fire of the components mounted above it: relays k1, k2, k101 and the cable harness. The customer is extremely worried because of the strong smoke emission. The inner parts of the table were completely polluted by sooty particles of the burned cable insulation. Root cause is pending investigation. Corrective action is pending investigation. Risk assessement is completed. No injury or mistreatment has been reported.
Patient Sequence No: 1, Text Type: D, B5
[8303298]
Severity: 3 (critical). Reason: if the potential for fire is not mitigated, it could result in serious injury or death. Physician care required to treat for smoke inhalation. Probability: preliminary c (remote) reason: smouldering fire occured for 2 out of about 430 installed tables of type 550 txt. In both cases there was no injury reported. Fire retardant components wil prevent catastrophic fire once power is removed from main source. Most of the components are also surrounded by metal. It is also reasonable to expect that the burning smell will alert the user immediately and should provide ample time to remove power from system and remove patients from the treatment area to prevent smoke inhalation or serious injury. Several interlocks are in place which would power off the system in case of short circuits caused by defective printed circuit boards. The txt treatment table mentioned and above is identified as follows: material number 7346534, (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2009-00079 |
| MDR Report Key | 1559222 |
| Report Source | 07 |
| Date Received | 2009-11-30 |
| Date of Report | 2009-11-17 |
| Date of Event | 2009-11-13 |
| Date Mfgr Received | 2009-11-17 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2010-02-03 |
| 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 | MARK BURGESS |
| Manufacturer Street | 4040 NELSON AVE. |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9256028083 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS BRAND NAME: 550 TXT TABLE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2009-11-30 |
| Model Number | NA |
| Catalog Number | 7346534 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 4040 NELSON AVE. CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-30 |