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 2020-01-20 for ACHIEVA 1.5T NEW 781296 NA manufactured by Philips Healthcare.
[175737172]
Based on the provided information and tests performed on site, there is no indication of a malfunction of the mri system or coil used that contributed to the blistering. The injury is concluded to have been caused by a conductive material within the patients? Clothing. Contributing factors in this case: 10 scans with high sar values (> 2 w/kg) were executed in a short period of time, allowing no cool down time for the patient. The total administered specific energy dose of 4. 8 kj/kg exceeded the recommended limit of 3. 5 kj/kg.
Patient Sequence No: 1, Text Type: N, H10
[175737173]
Philips received a report related to a heating incident (striped shaped blistering on the patient? S abdomen) on an achieva 1. 5t mr system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2020-00005 |
| MDR Report Key | 9606869 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2012-05-16 |
| Date Added to Maude | 2020-01-20 |
| 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 4-6 P.O. BOX 10.000 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal | 5680 DA |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHIEVA 1.5T NEW |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-20 |
| Model Number | 781296 |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |