FDA Adverse Event
Malfunction
Summary report: N
STRESSVUE
MDR report key: 2002689
·
Received February 9, 2011
Report
- Report Number
- 1218950-2011-00354
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Report Date
- January 11, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- DPS
- PMA / PMN Number
- K022618
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED SEVERE ARTIFACTON 12 LEAD ECG. ST SEGMENT MAYBE INCORRECTLY AMPLIFIED. PHILIPS WAS UNABLE TO CONFIRM THE CUSTOMERS REPORTED PROBLEM. THERE WAS NO TROUBLE FOUND, NO REPAIR WAS DONE OR NECESSARY. THE DEVICE IS WORKING AS INTENDED. NO CAUSE COULD BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED SEVERE ARTIFACTON 12 LEAD ECG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRESSVUE | DPS | PHILIPS HEALTHCARE | 860295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |