MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2017-03-30 for LEKSELL GAMMA KNIFE ICON 11.1 manufactured by Elekta Instrument Ab.
[71214377]
The matchport is mounted in the gantry module. For version 11. 1, the matchport device must be configured in a special way. This special configuration of the matchport device is described in the installation manual but not in the corrective maintenance manual. After the exchange of the gantry module, the matchport device may thus not be configured properly resulting in risk to the service technician or malfunction of the gantry. If the service technician does a kv generator calibration after the exchange, the technician will find out that the configuration is missing because they would not be able to perform the calibration.
Patient Sequence No: 1, Text Type: N, H10
[71214378]
When replacing a faulty gantry module on a new installation, it was discovered that settings controlling the kv generator using lantronix/matchport were lost as they are stored locally in the gantry module.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2017-00004 |
| MDR Report Key | 6445391 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-30 |
| Date Mfgr Received | 2017-03-02 |
| Date Added to Maude | 2017-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INSTRUMENT AB |
| Manufacturer Street | KUNGSTENSGATAN 18 PO BOX 7593 |
| Manufacturer City | STOCKHOLM, SE10393 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE103 93 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE ICON |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2017-03-30 |
| Model Number | 11.1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | KUNGSTENSGATAN 18 PO BOX 7593 STOCKHOLM, SE10393 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-30 |