FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MX40 802.11A/B/G
MDR report key: 3770483
·
Received March 5, 2014
Report
- Report Number
- 1218950-2014-01185
- Event Type
- Malfunction
- Date Received
- March 5, 2014
- Report Date
- February 18, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY WERE NOT GETTING AUDIO FROM THEIR MX40 DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134095 | INTELLIVUE MX40 802.11A/B/G | DSI | PHILIPS MEDICAL SYSTEMS | 865352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |