FDA Adverse Event
Malfunction
Summary report: N
DIGITRAK XT
MDR report key: 16408640
·
Received February 21, 2023
Report
- Report Number
- 16408640
- Event Type
- Malfunction
- Date Received
- February 21, 2023
- Date of Event
- January 17, 2023
- Report Date
- January 26, 2023
- Manufacturer
- PHILIPS MEDICAL SYSTEMS HSG
- Product Code
- MWJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A CODE "303 DEFECTIVE CARD" ON THE HOLTER MONITOR. IT NEEDED TO BE REPLACED WITH NEW MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1205284 | DIGITRAK XT | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) | MWJ | PHILIPS MEDICAL SYSTEMS HSG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |