FDA Adverse Event
Other
Summary report: N
STESSWRITER EXERCISE TESTING SYSTEM
MDR report key: 309183
·
Received December 13, 2000
Report
- Report Number
- 1218950-2000-00246
- Event Type
- Other
- Date Received
- December 13, 2000
- Report Date
- November 17, 2000
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- DQK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CE
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN INTERMITTENT PROBLEM WITH THE STRESSWRITER EXERCISE TESTING SYSTEM. ONCE THE SYSTEM STARTS, THE SPEED INCREASES RAPIDLY AND CANNOT BE CONTROLLED BY THE USER. SHUTTING DOWN THE SYSTEM CAN RESET IT. THE CUSTOMER ALSO REPORTED THAT THE SYSTEM STOPS SOMETIMES BY ITSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STESSWRITER EXERCISE TESTING SYSTEM | STRESS TEST SYSTEM | DQK | AGILENT TECHNOLOGIES, INC. | M2488A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |