MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-03 for IC PROFILER-MR 1123 manufactured by Sun Nuclear Corp..
[16310032]
Staff using an ic profiler-mr at (b)(6) radiation oncology reported their ic profiler-mr unit that was resting on the couch moved when the couch was translated into a magnetic field of a viewray delivery system. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[16385643]
The ic profiler-mr is not used in the presence of a patient. However, staff setting up the ic profiler-mr for measurement of an installed viewray delivery system could experience a pinch hazard between the covers on the delivery system and the ic profiler-mr if it is attracted towards the delivery system by the magnetic field. Investigation identified an assembly error of this unit. There were 3 units manufactured in the lot and 9 units manufactured in total. As part of the investigation of this incident, all units manufactured have been evaluated. Data obtained confirmed 2 units contained the assembly error. These units have been removed and repaired.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038814-2014-00001 |
| MDR Report Key | 4084960 |
| Report Source | 06 |
| Date Received | 2014-09-03 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2014-08-06 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-09-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHAN LEE |
| Manufacturer Street | 3275 SUNTREE BLVD |
| Manufacturer City | MELBOURNE FL 32940 |
| Manufacturer Country | US |
| Manufacturer Postal | 32940 |
| Manufacturer Phone | 3212596862 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IC PROFILER-MR |
| Generic Name | IC PROFILER-MR |
| Product Code | LHO |
| Date Received | 2014-09-03 |
| Returned To Mfg | 2014-08-08 |
| Model Number | 1123 |
| Lot Number | W92327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUN NUCLEAR CORP. |
| Manufacturer Address | MELBOURNE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-03 |