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