MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for SENSE NV COIL 1.5T (16CH) manufactured by Carma Salud, S.l..
[108084518]
The investigation is still ongoing for this event. When the investigation is complete a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[108084519]
A female patient was positioned head first, supine being scanned for a lower spine where the light visor was centered over lower spine. Patient was lay on a sense spine coil 1. 5t in combination with a sense nv coil 1. 5t. Patient came in contact with the balun of the sense nv coil which had become hot to the touch (unknown temp). Patient experienced a burn of what appears to be approximately 2. 5cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056069-2018-00003 |
| MDR Report Key | 7508702 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-08 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2018-05-11 |
| 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. KENNETH REVENNAUGH |
| Manufacturer Street | C/ DISC |
| Manufacturer City | MADRID 28022 |
| Manufacturer Country | SP |
| Manufacturer Postal | 28022 |
| Manufacturer G1 | PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SENSE NV COIL 1.5T (16CH) |
| Product Code | MOS |
| Date Received | 2018-05-11 |
| Lot Number | N/A |
| ID Number | SENSE SPINE 1.5T 15CH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARMA SALUD, S.L. |
| Manufacturer Address | C/ DISC?BOLO, 91-P4-2?A MADRID 28022 SP 28022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-11 |