MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-03-28 for NOT DETERMINED manufactured by Carma Salud, S.l..
[70979706]
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
[70979707]
Philips received a report from a customer related to a patient heating incident with an achieva 1. 5t mr system. A female patient was examined with the sense nv coil and sense spine coil and sustained a 2nd to 3rd degree heating injury on the left lower back.
Patient Sequence No: 1, Text Type: D, B5
[99104198]
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. System tests were conducted to emulate the fault condition. A heat test was conducted. The interaction of the coil with the body coil was measured and the worst case position was noted. The total scan time during the clinical scan was ~1 hour; therefore, the heat test was performed for 1 hour. After the heat test the nv and spine coil were evaluated using an ir camera. The surface temperature of the coil exceeded the maximum allowable temperature of 41 c (patient contact)/51 c (patient casual contact) around the area that the patient burn was reported. The coil was thoroughly checked on the bench for signs of excessive heating. None were observed and the coil measurements seemed to be within specification. Probable cause for overheat: the patient was put through multiple high sar scans with powers ranging from 6. 6 kw to 16 kw with most scans being around 15 kw. This is not recommended. Though the surface temperatures of the coil did go beyond 51 c at the patient casual contact surface it is not plausible for a 66 c surface to cause 3rd degree burns unless the patient was laying directly on the hot surface. The b1 tests did not reveal any dangerous cable currents that might have caused rf burns. Though there were a few mistuned decouplers in the coil, it was shown that the mistuned decouplers did not contribute to the temperature raise as a similar temperature raise was observed after the fault was fixed. The ifu indicates that consecutive high sar scans should not be performed. Consecutive high sar scans with direct patient contact can result in a harmful condition. A plausible explanation for the cause of the incident could be that the patient? S body was in contact with the transmit body coil or that the cable was routed underneath the patient making contact. Both of these conditions are mentioned as safety hazards in the ifu. From the analysis and the tests performed, the fault condition is not reproducible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2017-00001 |
| MDR Report Key | 6438512 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-02-28 |
| Date Added to Maude | 2017-03-28 |
| 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 |
| Generic Name | NOT DETERMINED |
| Product Code | MOS |
| Date Received | 2017-03-28 |
| Returned To Mfg | 2017-10-16 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-28 |