MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-04-02 for VERIFLEX VERSION 2.04 109.020 manufactured by Nucletron Bv.
[16796464]
During the first treatment of a pt, two of two fields were treated. The therapist then prepared to take a port film. The accelerator attempted to deliver 250 mu, but when the therapist realized the error, 100 mu had been delivered. This exceeded the total prescribed mu by 100. If esc key is pressed on the veriflex keyboard, after rad-on and before rad-off, veriflex will fail to record treatment and will not register the treatment as being complete. It is then possible to re-treat the same field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121753-1998-00013 |
| MDR Report Key | 161701 |
| Report Source | 05 |
| Date Received | 1998-04-02 |
| Date of Report | 1998-03-20 |
| Date of Event | 1997-10-15 |
| Date Facility Aware | 1997-10-15 |
| Report Date | 1998-03-20 |
| Date Mfgr Received | 1997-10-15 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFLEX |
| Generic Name | RECORD AND VERIFY SYSTEM |
| Product Code | KPZ |
| Date Received | 1998-04-02 |
| Model Number | VERSION 2.04 |
| Catalog Number | 109.020 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 157444 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | WAARDGELDER 1 VEENENDAAL NL 3905 TH |
| 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 |