FDA Adverse Event
Injury
Summary report: N
SINGA HDX 1.5T
MDR report key: 1298168
·
Received January 28, 2009
Report
- Report Number
- 2183553-2009-00003
- Event Type
- Injury
- Date Received
- January 28, 2009
- Date of Event
- December 26, 2008
- Report Date
- January 2, 2009
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- PMA / PMN Number
- K052293
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
A PATIENT REPORTEDLY COMPLAINED OF HEAT ON HIS RIGHT ARM DURING A SHOULDER COIL SCAN. A WEEK LATER, THE PT CALLED THE SITE TO REPORT THAT HE HAD A QUARTER SIZE BLISTER. THE TECHNOLOGIST RECALL CHECKING THE PT AT THE TIME OF THE EVENT AND THE PT WAS WARM BUT NO REDNESS WAS VISIBLE ON THE PT'S SKIN. THE PT WAS VERY LARGE SO EXTRA PADDING WAS NOT ABLE TO BE USED. THE PT WAS NOT PADDED BETWEEN HIS BODY AND ARMS. THE PULSE SEQUENCE AND DURATION OF THE SCAN IS AS FOLLOWS: IOC: 28 SEC; CAL: 13 SEC; AXIAL MERGE T2 GRADIENT: 4 MIN 15 SEC; CORONAL T2: 4 MIN 28 SEC; CORONAL PD: 4 MIN 59 SEC; CORONAL T1: 4 MIN 31 SEC; SAGITTAL PD: 6 MIN 23 SEC; CORONAL T1: 4 MIN 35 SEC (REPEAT); SAGITTAL T2: 5 MIN 42 SEC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGA HDX 1.5T | LNH | GE MEDICAL SYSTEMS, LLC | 2395001-3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |