FDA Adverse Event
Injury
Summary report: N
INTERA 1.5T
MDR report key: 4112905
·
Received September 17, 2014
Report
- Report Number
- 3003768277-2014-00100
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 29, 2014
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K001987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
PHILIPS RECEIVED A REPORT FROM A CUSTOMER THAT A PATIENT WAS SCANNED WITH THE SENSE SPINE COIL FOR A LUMBAR SPINE EXAMINATION. THE PATIENT WAS COVERED WITH A BLANKET, WHICH CAUGHT FIRE JUST AFTER THE MR EXAMINATION WAS STARTED. THE PATIENT EXPERIENCED A HEATING SENSATION IN THE RIGHT SHOULDER, BUT NO SERIOUS INJURY WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576096 | INTERA 1.5T | LNH | PHILIPS HEALTHCARE | 781195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |