FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 2212717
·
Received July 12, 2011
Report
- Report Number
- 9610816-2011-00376
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Report Date
- June 16, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K071426
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PHILIPS MMS X2 SERVER HAD BEEN DROPPED. NO PT HARM WAS REPORTED. IN ABUNDANCE OF CAUTION AND AS NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AS TO WHETHER THIS WAS AN ACCIDENTAL DROP, PHILIPS WILL REPORT THIS INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS ISSUE 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 A PHILIPS MMS X2 SERVER HAD BEEN DROPPED. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | PHILIPS MEDICAL SYSTEMS | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |