FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 845881
·
Received March 12, 2007
Report
- Report Number
- 845881
- Event Type
- Malfunction
- Date Received
- March 12, 2007
- Date of Event
- March 11, 2007
- Report Date
- March 12, 2007
- Manufacturer
- OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS
- Product Code
- JCX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PATIENT HAD BEEN INTERMITTENTLY THROWING UP GREEN BILIOUS FLUID DURING THE NIGHT. DURING ASSESSMENT AT 0900, NURSE FOUND THAT SUCTION HEAD WAS NOT FUNCTIONING(X2). THE NASAL GASTRIC TUBE WAS HOOKED UP TO FUNCTIONING SUCTION HEAD. ONE LITER OF FLUID DRAINED WITHIN THIRTY MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | SUCTION REGULATOR | JCX | OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS | * | * | |
| 2 | * | SUCTION REGULATOR | JCX | OHMEDA MEDICAL, A PART OF GE MEDICAL SYSTEMS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |