FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, ELECTROCARDIOGRAPH
MDR report key: 2133291
·
Received May 12, 2011
Report
- Report Number
- 8021950-2011-00008
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- UNOMEDICAL, LTD.
- Product Code
- DRX
- PMA / PMN Number
- K990113
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BASED ON CURRENT INFO, RECURRENCE OF THIS MALFUNCTION WOULD LIKELY LEAD TO A SERIOUS ADVERSE EVENT. LEADS THAT RESULTS IN ERRONEOUS RESULTS OR ASYSTOLE ON THE ECG TRACING WOULD LIKELY CAUSE A MISDIAGNOSIS AND INAPPROPRIATE MEDICAL TREATMENT OF THE PT. REPORTED TO THE FDA ON (B)(4) 2011.
Description of Event or Problem · 1
REPORTED BY THE COMPLAINANT AS FOLLOWS: THERE IS NO TRANSMISSION SIGNAL FROM THE ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTRODE, ELECTROCARDIOGRAPH | ELECTROCARDIOGRAPH, ELECTRODE | DRX | UNOMEDICAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |