FDA Adverse Event
Death
Summary report: N
M3155 RELEASE L.0 UPGRADE
MDR report key: 2945937
·
Received February 1, 2013
Report
- Report Number
- 1218950-2013-00162
- Event Type
- Death
- Date Received
- February 1, 2013
- Date of Event
- January 5, 2013
- Report Date
- January 7, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K062271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THERE WAS NO ALARM HEARD AT THE CENTRAL STATION. THE PATIENT EXPIRED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THAT THERE WAS NO ALARM HEARD AT THE CENTRAL STATION. THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44167 | M3155 RELEASE L.0 UPGRADE | MHX | PHILIPS MEDICAL SYSTEMS | M3155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |