FDA Adverse Event
Injury
Summary report: N
F-801 PORTABLE RO INSERT SYSTEM
MDR report key: 213275
·
Received March 5, 1999
Report
- Report Number
- 3019131-1999-00001
- Event Type
- Injury
- Date Received
- March 5, 1999
- Date of Event
- February 9, 1999
- Report Date
- February 9, 1999
- Manufacturer
- ZYZATECH WATER SYSTEMS, INC.
- Product Code
- JRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLAINANT STATED THAT, OVER A PERIOD OF TIME, ONE OF CO'S PRODUCTS HAD "TIPPED OVER", CAUSING INJURY TO AN OPERATOR WHO WAS TRYING TO PREVENT IT FROM FALLING. THE COMPLAINANT STATED THAT THIS EVENT HAS OCCURRED SEVERAL TIMES, CAUSING INJURY TO THREE OPERATORS. ALLEGEDLY, ONE OF THE INJURIES IS PERMANENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | F-801 PORTABLE RO INSERT SYSTEM | PORTABLE REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS | JRS | ZYZATECH WATER SYSTEMS, INC. | 12340 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Disability | FRESENIUS 2008H DIALYSIS MACHINE |