FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 575546
·
Received February 7, 2005
Report
- Report Number
- 1216146-2005-00001
- Event Type
- Malfunction
- Date Received
- February 7, 2005
- Date of Event
- December 22, 2004
- Report Date
- January 10, 2005
- Manufacturer
- J. H. EMERSON CO.
- Product Code
- JCX
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT DESC: PT WAS ON 40CM SUCTION AND PUMP SIMPLY SHUT OFF. THE TOP OF THE PUMP WAS HOY TO THE TOUCH. DEVICE USAGE PROBLEM DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | JCX | J. H. EMERSON CO. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |