FDA Adverse Event
Malfunction
Summary report: N
CH 2000 STRESS TEST SYSTEM
MDR report key: 215246
·
Received March 17, 1999
Report
- Report Number
- 1225215-1999-00001
- Event Type
- Malfunction
- Date Received
- March 17, 1999
- Date of Event
- February 16, 1999
- Report Date
- March 17, 1999
- Manufacturer
- CAMBRIDGE HEART, INC.
- Product Code
- DPS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OPERATOR REPORTED THAT WHILE PATIENT WAS RUNNING STRESS PROTOCOL THE PATIENT COMPLAINED OF CHEST DISCOMFORT. THE OPERATOR HIT THE STOP BUTTON TO STOP THE TREADMILL, BUT THE TREADMILL DID NOT STOP. PATIENT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CH 2000 STRESS TEST SYSTEM | ELECTROCARDIOGRAPH | DPS | CAMBRIDGE HEART, INC. | CH 2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |