MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-24 for 4 CH SENSE SHOULDER COIL 1.5T 9896-030-13431 manufactured by Carma Salud, S.l..
[83485879]
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
[83485880]
Burn incident during mr exam of right shoulder (right upper arm) after the exam the patient complained of a heating sensation on the right arm during the exam. The nurse did not find any major injuries. The patient went home without any further actions/treatment. Two weeks later the patient contacted hospital about burn injury. At that moment a 3rd degree injury approx. 5 cm was observed.
Patient Sequence No: 1, Text Type: D, B5
[92939921]
Patient Sequence No: 1, Text Type: N, H10
[92940245]
The coil was returned from the customer and an engineering evaluation was conducted. Engineering conducted external and internal visual inspections with no defects or indication of burn found. Bench and system tests were performed to find potential causes that might have resulted in patient harm. It was observed that the balun in the baseplate was out of specification and this might have been due to aged components. This is a single fault, and the cable balun should have been able to handle the keep the cable currents to a low enough value that no harm was caused. Cable b1 tests revealed that the cable currents were indeed within the safe operating range for a single fault condition. An rf power much higher than the one used for the patient scan was used to measure potential rf heating. No excessive heating was observed. From this data, it was not easy to reproduce the harm condition. However, if a second fault, in the form of the operator incorrectly routing the cables close to the human body occurred, then with a single fault condition such harm may be possible. In conclusion, one of the baluns was slightly mistuned and resulted in a single fault condition. The coil was tested in this single fault condition, and an unsafe condition was not observed. One may, however, envision that a second fault condition happened when the cable was routed very close to patient? S arm. The harm might have occurred due to operator error while routing the cable. A warning is included in the instructions for use (4535-302-91111 rev. 7) invivo magnetic resonance imaging coils which states: do not cross or loop cables. Arcing and patient burns could result. Route cables out of the magnet so that they do not touch the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2017-00002 |
| MDR Report Key | 6816596 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-08-24 |
| 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 | 3 |
| Brand Name | 4 CH SENSE SHOULDER COIL 1.5T |
| Generic Name | 4-CH SENSE SHOULDER COIL 1.5T |
| Product Code | MOS |
| Date Received | 2017-08-24 |
| Model Number | 9896-030-13431 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-24 |