MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-05-27 for EXRADIN A12 92700 manufactured by Standard Imaging, Inc..
[22182502]
Customer alleged that the exradin a12 ionization chamber has a significant difference in the calibration factor from that provided on the calibration certificate from the accredited dosimetry calibration laboratory (adcl). This device is used for the quality assurance checks on radiation therapy devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184007-2003-00001 |
| MDR Report Key | 469194 |
| Report Source | 05 |
| Date Received | 2003-05-27 |
| Date of Report | 2003-05-22 |
| Date of Event | 2003-05-07 |
| Date Mfgr Received | 2003-05-07 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2003-07-03 |
| 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 | 0 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RAYMOND RIDDLE, VP, RA |
| Manufacturer Street | 7601 MURPHY DRIVE |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088310025 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXRADIN |
| Generic Name | IONIZATION CHAMBER |
| Product Code | LHO |
| Date Received | 2003-05-27 |
| Model Number | A12 |
| Catalog Number | 92700 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458069 |
| Manufacturer | STANDARD IMAGING, INC. |
| Manufacturer Address | 7601 MURPHY DR. MIDDLETON WI 535622766 US |
| Baseline Brand Name | EXRADIN |
| Baseline Generic Name | IONIZATION CHAMBER |
| Baseline Model No | A12 |
| Baseline Catalog No | 92700 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-05-27 |