MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for ADAPTINSIGHT I2C manufactured by Iba (ion Beam Applications).
[129616049]
Iba has been informed that on (b)(6) 2018 during daily checks performed on the system, an unexpected shift in position of a phantom installed on the patient positioning system was observed. The processing unit was power cycled and adapt insight workstation was restarted. Afterwards, the same test as above was performed and this time the phantom was still aligned properly. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000256071-2018-00005 |
| MDR Report Key | 8120233 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2018-11-30 |
| 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 | MS. SYLVIANE BERGER |
| Manufacturer Street | CHEMIN DU CYCLOTRON 3 |
| Manufacturer City | LOUVAIN-LA-NEUVE, 01348 |
| Manufacturer Country | BE |
| Manufacturer Postal | 01348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADAPTINSIGHT |
| Generic Name | I2C |
| Product Code | LHN |
| Date Received | 2018-11-30 |
| Model Number | I2C |
| Catalog Number | I2C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IBA (ION BEAM APPLICATIONS) |
| Manufacturer Address | CHEMIN DU CYCLOTRON 3 LOUVAIN-LA-NEUVE, 01348 BE 01348 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |