FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 3182293
·
Received June 10, 2013
Report
- Report Number
- 9610816-2013-00126
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Report Date
- May 22, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- 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): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT X2 GIVES NEITHER A VISUAL NOR AN ACOUSTIC ALARM. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT OR ANY PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261899 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | PHILIPS MEDICAL SYSTEMS | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |