FDA Adverse Event
Malfunction
Summary report: N
MX40 2.4 GHZ SMART HOPPING
MDR report key: 4093059
·
Received September 10, 2014
Report
- Report Number
- 1218950-2014-05465
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Report Date
- September 2, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS NO AUDIO FROM AN MX40 DEVICE. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559662 | MX40 2.4 GHZ SMART HOPPING | DSI | PHILIPS MEDICAL SYSTEMS | 865351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |