FDA Adverse Event
Death
Summary report: N
NONE
MDR report key: 1882388
·
Received October 20, 2010
Report
- Report Number
- 1218950-2010-01976
- Event Type
- Death
- Date Received
- October 20, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 18, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER IS REQUESTING RETROSPECTIVE DATA FOLLOWING A PT DEATH. NO INFO WAS PROVIDED THAT WOULD INDICATE ANY DEVICE OR LABELING PROBLEM. 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 RETROSPECTIVE DATA FOLLOWING A PT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | MKJ | PHILIPS HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |