MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-07-21 for AVANZA G360 manufactured by Mds Nordion.
[3394329]
A report was rec'd that there is a potential for excessive surface dose when the beam passes through the carbon fibre stretcher top opening. This was discovered by the customer during installation.
Patient Sequence No: 1, Text Type: D, B5
[10661624]
It was noted by the customer during acceptance testing that the beam transmission was unusual when the gantry was positioned at 180 degrees through the stretcher top opening. Testing was performed at (b)(4) and confirmed the customer's findings. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022247-2006-00007 |
| MDR Report Key | 3057461 |
| Report Source | 07 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-10 |
| Date of Event | 2006-06-23 |
| Date Mfgr Received | 2006-06-23 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2013-04-16 |
| 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 | MR ROSS KACHANIWSKY |
| Manufacturer Street | 447 MARCH ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2K 1X8 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 1X8 |
| Manufacturer Phone | 6135923400 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVANZA |
| Generic Name | PATIENT POSITIONING TABLE |
| Product Code | JAI |
| Date Received | 2006-07-21 |
| Model Number | AVANZA |
| Catalog Number | G360 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH ROAD OTTAWA, ONTARIO K2K1X8 CA K2K 1X8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |