FDA Adverse Event
Malfunction
Summary report: N
9.1MHZ PENCIL PROBE
MDR report key: 22122473
·
Received June 2, 2025
Report
- Report Number
- 22122473
- Event Type
- Malfunction
- Date Received
- June 2, 2025
- Date of Event
- May 14, 2025
- Report Date
- May 15, 2025
- Manufacturer
- PARKS MEDICAL ELECTRONICS, INC.
- Product Code
- JOP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DOPPLER ERROR- DOSN'T WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26944 | 9.1MHZ PENCIL PROBE | TRANSDUCER, ULTRASONIC | JOP | PARKS MEDICAL ELECTRONICS, INC. | 832-1910-11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |