MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1998-11-11 for * VERIFLEX RECORD & VERIFY RELEASE VA. 2.05.16 manufactured by Nucletron Bv.
[14870009]
Transferring pt data treatment fields from a motor/wedge machine (philips sl75-5), having defined dose with wedge and dose without wedge (and wedge mu and total mu), to a mechanical wedge machine (siemens kd2). At reference validation at th kd2, mus are blanked out (which is acceptable), indicating previous station mu and wedge mu values outlined in red boxes on the display screen. However the fractional dose is made equal to the previous field dose without the wedge, instead of the total value (dose with wedge + dose without wedge). This means the sys will store dose incorrectly if the operator accepts the transfer value without verifying the value displayed. The transferred dose will be less than the actual daily dose for the field. Making the accumulated dose incorrect. The deficit is dependent on the fractional dose without wedge, which is always less than the dose actually delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121753-1998-00027 |
| MDR Report Key | 197836 |
| Report Source | 01,07 |
| Date Received | 1998-11-11 |
| Date of Report | 1998-11-11 |
| Date of Event | 1998-10-13 |
| Date Facility Aware | 1998-10-22 |
| Report Date | 1998-11-11 |
| Date Added to Maude | 1998-11-20 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | IZF |
| Date Received | 1998-11-11 |
| Model Number | VERIFLEX RECORD & VERIFY |
| Catalog Number | RELEASE VA. 2.05.16 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 192204 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | WAARDGELDER 1 TH VEENENDAAL NL 3905 |
| Baseline Brand Name | * |
| Baseline Generic Name | * |
| Baseline Model No | VERIFLEX RECORD |
| Baseline Catalog No | RELEASE VA. 2.05.16 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-11-11 |