FDA Adverse Event Death Summary report: N

PHILIPS INFORMATION CENTER

MDR report key: 2221342 · Received August 17, 2011

Report

Report Number
1218950-2011-02356
Event Type
Death
Date Received
August 17, 2011
Date of Event
August 8, 2011
Report Date
August 9, 2011
Manufacturer
PHILIPS HEALTHCARE - ANDOVER
Product Code
MHX
PMA / PMN Number
K011093
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AL, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE CUSTOMER IS REQUESTING ASSISTANCE TO RETRIEVE LOGS ON A PT THAT HAD EXPIRED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 IS REQUESTING ASSISTANCE TO RETRIEVE LOGS ON A PT THAT HAD EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHILIPS INFORMATION CENTER MHX, DRT MHX PHILIPS HEALTHCARE - ANDOVER M3150B

Patients

Seq Age Sex Outcome Treatment
1 Death