FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 4232315
·
Received September 17, 2014
Report
- Report Number
- 9610816-2014-00235
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Report Date
- August 27, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEM
- Product Code
- MHX
- PMA / PMN Number
- K071426
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED A SPEAKER MALFUNCTION. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574059 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | MHX | PHILIPS MEDICAL SYSTEM | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |