FDA Adverse Event
Death
Summary report: N
AGILENT INFO CENTER
MDR report key: 2231440
·
Received August 26, 2011
Report
- Report Number
- 1218950-2011-02289
- Event Type
- Death
- Date Received
- August 26, 2011
- Report Date
- August 1, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MHX
- PMA / PMN Number
- K011093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED A DEATH AND REQUESTED ASSISTANCE IN OBTAINING RETROSPECTIVE DATA ON THE DECEASED PT. NO MALFUNCTION WAS ALLEGED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 REPORTED A DEATH AND REQUESTED ASSISTANCE IN OBTAINING RETROSPECTIVE DATA ON THE DECEASED PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AGILENT INFO CENTER | MHX, DRT | MHX | PHILIPS HEALTHCARE - ANDOVER | M3150A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |