FDA Adverse Event
Death
Summary report: N
INTELLIVUE INFO CENTER
MDR report key: 3716354
·
Received February 25, 2014
Report
- Report Number
- 1218950-2014-01682
- Event Type
- Death
- Date Received
- February 25, 2014
- Report Date
- March 20, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K081983
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THEY HAD A PATIENT INCIDENT IN WHICH A PATIENT DIED. THE PHILIPS DEVICE WAS NOT A FACTOR BUT THEY WANTED ASSISTANCE WITH THE RETRIEVAL OF LOG DATA FOR BED 331-1 ON (B)(6) 2014 BETWEEN 21:13:37 AND (B)(6) 2014, AT 03:52:13. THE CUSTOMER STATED THAT THEY HAD IEM PAGING IN USE AND NOTED THAT THE EMERGING ALARM MESSAGE LOG SHOWED AN ECG LEADS OFF ALARM AT 02:33:58 AND AN ASYSTOLE AT 03:50:24. THE CUSTOMER WANTED ASSISTANCE WITH UNDERSTANDING WHAT THE SEQUENCE OF EVENTS MAY HAVE BEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117058 | INTELLIVUE INFO CENTER | MHX | PHILIPS MEDICAL SYSTEMS | M3150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |