FDA Adverse Event
Summary report: N
DASH
MDR report key: 3254099
·
Received April 12, 2013
Report
- Report Number
- 3254099
- Date Received
- April 12, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 12, 2013
- Manufacturer
- GENERAL ELECTRIC CO
- Product Code
- MHX
- Report Source
- User Facility report
- Reporter Location
- IA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PRODUCT ALERT: GE HEALTHCARE HAS RECENTLY BECOME AWARE OF A POTENTIAL SAFETY ISSUE DUE TO INTERMITTENT NOISE ON ECG AND/OR RESPIRATION WAVEFORMS ASSOCIATED WITH MOVEMENT OF THE ECG CONNECTOR ON THE DASH, PDM, AND/OR TRAM MODULE. THIS ISSUE HAD NOT BEEN IDENTIFIED AT OUR FACILITY, BUT STAFF HAVE BEEN EDUCATED ON THE PRODUCT ALERT. ECG AND RESPIRATION SIGNAL NOISE CAUSED BY DASH, PDM, AND/OR TRAM ECG CABLE CONNECTOR MOVEMENT MAY RESULT IN REDUCED ECG, RESPIRATION AND ARRHYTHMIA DETECTION PERFORMANCE. NOT ALL PRODUCT CODES WERE AFFECTED AND WE DID NOT HAVE THE MONITOR WITH ANY EFFECTED PRODUCT CODES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159887 | DASH | MONITOR, PHYSIOLOGICAL, PATIENT | MHX | GENERAL ELECTRIC CO | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |