FDA Adverse Event
Malfunction
Summary report: N
COMMANDER XG
MDR report key: 879279
·
Received May 18, 2007
Report
- Report Number
- 2029299-2007-00001
- Event Type
- Malfunction
- Date Received
- May 18, 2007
- Date of Event
- May 2, 2007
- Report Date
- May 17, 2007
- Manufacturer
- RESONANCE TECHNOLOGY, INC.
- Product Code
- LNH
- PMA / PMN Number
- K994351
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
REP IMMEDIATELY FLEW IN 2007 AND VISITED MEDICAL CENTER TO ASSESS THE SITUATION WITH THE AUTHORIZATION OF DIRECTOR OF CLINICAL ENGINEERING. HOWEVER, UPON REP'S ARRIVAL, THE FACILITY'S ATTORNEY DID NOT ALLOW REP TO VISIT THE MRI ROOM NOR SEE THE EQUIPMENT, BECAUSE OF LEGAL ISSUES.
Description of Event or Problem · 1
HEADSET MICROPHONE MELTED AND FELL ON PT'S CHEST CAUSING A BURN TO THE PT'S SKIN AND PT DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMMANDER XG | LNH | RESONANCE TECHNOLOGY, INC. | RTC-CXG-SYS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |