FDA Adverse Event
Malfunction
Summary report: N
MX40 2.4 GHZ SMART HOPPING
MDR report key: 3945296
·
Received May 6, 2014
Report
- Report Number
- 1218950-2014-02476
- Event Type
- Malfunction
- Date Received
- May 6, 2014
- Report Date
- April 9, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED NO AUDIO FROM THE MX40. THERE WAS NO REPORT OF PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271445 | MX40 2.4 GHZ SMART HOPPING | DSI | PHILIPS MEDICAL SYSTEMS | 865351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |