FDA Adverse Event
Malfunction
Summary report: N
MX40 1.4 GHZ SMART HOPPING
MDR report key: 5993219
·
Received October 3, 2016
Report
- Report Number
- 1218950-2016-06219
- Event Type
- Malfunction
- Date Received
- October 3, 2016
- Report Date
- September 8, 2016
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTED IN ERROR AND SHOULD HAVE STATED AS A 30 DAY REPORT.
Description of Event or Problem · 1
IT WAS REPORTED AT BENCH REPAIR THERE WAS AN ISSUE FOUND WITH NO AUDIO FROM THE MX40. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF A PATIENT INJURY OR HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647116 | MX40 1.4 GHZ SMART HOPPING | MX40 1.4 GHZ SMART HOPPING | DSI | PHILIPS MEDICAL SYSTEMS | 865350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |