MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-04-02 for VERIFLEX VERSION 2.04 109.020 manufactured by Nucletron Bv.
[123599]
Facility reported that when using veriflex with their varian 2100c linac, a server crash occurred which caused the corruption of the data base, the swapping of jaw parameters and irradiation of an area adjacent to the prescribed treatment area. This was not detected because the light field was not utilized to verify treatment on the second field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121753-1998-00001 |
| MDR Report Key | 161694 |
| Report Source | 06 |
| Date Received | 1998-04-02 |
| Date of Report | 1998-02-13 |
| Date of Event | 1997-12-31 |
| Date Reported to Mfgr | 1998-02-17 |
| Date Added to Maude | 1998-04-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFLEX |
| Generic Name | RECORD AND VERIFY SYSTEM |
| Product Code | IZF |
| Date Received | 1998-04-02 |
| Model Number | VERSION 2.04 |
| Catalog Number | 109.020 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157437 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | WAARDGELDER 1 TH VEENENDAAL NL 3905 |
| Baseline Brand Name | VERIFLEX |
| Baseline Generic Name | RECORD AND VERIFY SYSTEM |
| Baseline Model No | VERSION 2.04 |
| Baseline Catalog No | 109.02000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-02 |