MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-08-31 for CENTRAL AXIS MARKER UNK manufactured by Medtec, Inc. (dba. Civco Medical Solutions).
[1133572]
Therapist interrupted after initial setup and the device (central axis marker) was left in the wedge mount assembly. When treating there was no accessory interlock coded on device (central axis marker) in the linac. Treated patient with the device (central axis marker) still in place. Measurements of the attenuation of the polycarbonate material of the device (central axis marker) showed an underdose of 5% in the treatment volume beyond the 5x5cm. No correction for underdose was required/ reported.
Patient Sequence No: 1, Text Type: D, B5
[8314168]
Method: device was not available for evaluation. The customer and civco medical engineer reviewed the situation via phone. Device is delivered to customer uncoded, meaning that the linac dose not know it is in place when it is inserted into the head/wedge mount assembly. Manufacturer recommends that they should code it (fill in the appropriate holes to match their bb tray). This way the system will let them image with it in, but not treat - it will cause an interlock and prevent them from treating until they pull the tray. Conclusion: user error caused event as device was not removed prior to treatment. Device was not coded prior to use which prevents treating with the tray in place and this contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2009-00002 |
| MDR Report Key | 1461400 |
| Report Source | 06 |
| Date Received | 2009-08-31 |
| Date of Report | 2009-08-28 |
| Date of Event | 2009-08-06 |
| Date Mfgr Received | 2009-08-06 |
| Date Added to Maude | 2010-02-02 |
| 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 Street | 1401 8TH ST. S.E. |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127378688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRAL AXIS MARKER |
| Generic Name | CENTRAL AXIS MARKER |
| Product Code | IWE |
| Date Received | 2009-08-31 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS) |
| Manufacturer Address | 1401 8TH ST. S.E. ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-31 |