FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 3060675
·
Received March 28, 2013
Report
- Report Number
- 9610816-2013-00075
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Report Date
- March 4, 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): PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A LOUDSPEAKER ERROR. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127266 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | PHILIPS MEDICAL SYSTEMS | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |