FDA Adverse Event
Injury
Summary report: N
SIGNA CVI 1.5T
MDR report key: 1678263
·
Received May 7, 2010
Report
- Report Number
- 2183553-2010-00013
- Event Type
- Injury
- Date Received
- May 7, 2010
- Date of Event
- March 17, 2010
- Report Date
- March 17, 2010
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- PMA / PMN Number
- K980114
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE HAS INITIATED AN INVESTIGATION OF THE EVENT. ADDITIONAL DETAILS OF THE EVENT IS CORRECTLY BEING REQUESTED FROM THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH 30% HEARING LOSS AFTER AN MR SCAN. EAR PLUGS WITH A DECIBEL LEVEL OF 30 WERE REPORTED TO HAVE BEEN USED DURING THIS SCAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGNA CVI 1.5T | LNH | GE MEDICAL SYSTEMS, LLC | 2138300-16 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability | HEADSET |