FDA Adverse Event
Death
Summary report: N
PHILIPS INFORMATION CENTER
MDR report key: 3092236
·
Received April 29, 2013
Report
- Report Number
- 1218950-2013-01504
- Event Type
- Death
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 22, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K011093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE OVERVIEW ALARMS FOR A PATIENT IN THE ICU WERE NOT PROVIDED AT OTHER BEDSIDES. THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184737 | PHILIPS INFORMATION CENTER | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3150B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death |