FDA Adverse Event
Malfunction
Summary report: N
MX40 1.4 GHZ SMART HOPPING
MDR report key: 5233794
·
Received November 18, 2015
Report
- Report Number
- 1218950-2015-06215
- Event Type
- Malfunction
- Date Received
- November 18, 2015
- Report Date
- November 2, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED NO AUDIO FROM THE MX40. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF A PATIENT INJURY OR HARM
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763403 | MX40 1.4 GHZ SMART HOPPING | MX40 1.4 GHZ SMART HOPPING | DSI | PHILIPS MEDICAL SYSTEMS | 865350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |