MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-12 for IMRIS HC300 IOHV2 HEAD FLEX COIL 110840-000 manufactured by Deerfield Imaging, Inc..
[138641097]
The head coil in question is in the root cause evaluation stage and investigation is on-going as to whether the patient burn was caused by the flex coil, or personnel not following instructions for use, or other reasons. A follow-up report shall be submitted once sufficient information is available to determine the seriousness of the patient burn and the root cause evaluation.
Patient Sequence No: 1, Text Type: N, H10
[138641098]
A patient experienced a burn on his left forearm, approximately 5cm x 2 cm, during a procedure. The burn was not discovered until after the case and was reported to imris personnel as soon as it was determined that it most likely occurred from the mr scan during the procedure. The mri or director stated that she was not aware of any medical intervention required regarding the burn or how the hospital classified the burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2019-00003 |
| MDR Report Key | 8414797 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-10-26 |
| Date Added to Maude | 2019-03-12 |
| 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 | MR. TODD SPERLING |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal | 553434100 |
| Manufacturer Phone | 7632036344 |
| Manufacturer G1 | IMRIS-DEERFIELD IMAGING, INC. |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553434100 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMRIS HC300 IOHV2 HEAD FLEX COIL |
| Generic Name | HEAD IMAGING COIL |
| Product Code | MOS |
| Date Received | 2019-03-12 |
| Returned To Mfg | 2019-02-28 |
| Model Number | HC300 IOHV2 |
| Catalog Number | 110840-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEERFIELD IMAGING, INC. |
| Manufacturer Address | 5101 SHADY OAK ROAD MINNETONKA MN 553434100 US 553434100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |