FDA Adverse Event
Malfunction
Summary report: N
STRESSWRITER EXERCISE TESTING SYSTEM
MDR report key: 291399
·
Received August 15, 2000
Report
- Report Number
- 1218950-2000-00051
- Event Type
- Malfunction
- Date Received
- August 15, 2000
- Date of Event
- June 6, 2000
- Report Date
- June 7, 2000
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- DQK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS STARTED IN PRE-EXERCISE MODE (DEFAULT CONFIGURED AT 0.8 KM/H AND 0%). WHEN PT WAS WALKING ON THE TREADMILL, SUDDENLY THE EXERCISE DEVICE STARTED TO RUN A MAXIMUM SPEED (16, 1 KM/H) OUT OF CONTROL (BRUCE PROTOCOL WAS RUNNING). "PC" KEYBOARD DIDN'T RESPOND TO A STOP COMMAND; INSTEAD THE TREADMILL EMERGENCY STOP SWITCH, WHICH WOULDN'T BE REACHED BY THE PT, HAD TO BE PRESSED BY THE DR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRESSWRITER EXERCISE TESTING SYSTEM | STRESS TEST SYSTEM | DQK | AGILENT TECHNOLOGIES, INC. | M2488A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |