MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for INGENIA 1.5T 781396 manufactured by Philips Electronics Nederland B.v..
[183896000]
The patient heating form was send today to customer. Actually the event date is unknown, waiting information from customer. Translation of the attached email: good morning, (b)(6), thank you for the confirmation of the software version without any connection, (b)(6) alerted me to the occurrence of two very close cases of burns on the left side of the patient, in the normal direction. 1st case of proven burns on the breast, obese patient, push button (shirt) in contact with the mri hood and the breast. Mri in progress it has taken steps to isolate the patient's skin with the mri hood. No antenna elements (flexible antenna) are in contact with the patient. I am asking for your opinion. Can we rule out the hypothesis of heating at the level of a gradient coil? Of another component? Do you have any internal probes? A monitoring of the temperature or power consumption of a component located at this location? How could we prove the absence/presence of internal heating on mri? Your elements should allow us to make the right hypotheses. Thank you for your input, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2020-01003 |
| MDR Report Key | 9841492 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Event | 2020-01-30 |
| Date Facility Aware | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-17 |
| 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. DUSTY LEPPERT |
| Manufacturer Street | VEENPLUIS 6 |
| Manufacturer City | BEST 5684PC |
| Manufacturer Country | NL |
| Manufacturer Postal | 5684 PC |
| Manufacturer G1 | PHILIPS ELECTRONICS NEDERLAND B.V. |
| Manufacturer Street | VEENPLUIS 6 |
| Manufacturer City | BEST 5684PC |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 5684 PC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INGENIA 1.5T |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-03-17 |
| Model Number | INGENIA 1.5T |
| Catalog Number | 781396 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ELECTRONICS NEDERLAND B.V. |
| Manufacturer Address | VEENPLUIS 6 BEST 5684PC NL 5684 PC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |