FDA Adverse Event
Death
Summary report: N
CMS MAIN FRAME
MDR report key: 2043613
·
Received March 15, 2011
Report
- Report Number
- 9610816-2011-00142
- Event Type
- Death
- Date Received
- March 15, 2011
- Report Date
- March 11, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DRT
- PMA / PMN Number
- K002758
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT NO ALARMS WERE PROVIDED AND A PT DEATH OCCURRED. BASED ON AVAILABLE INFORMATION, THE CUSTOMER'S STATEMENTS INDICATE THAT ALARMS WERE CONFIGURED FOR INFINITE SUSPEND (USER ERROR). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT 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 NO ALARMS WERE PROVIDED AND A PT DEATH OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CMS MAIN FRAME | DRT | PHILIPS MEDICAL SYSTEMS | M1046A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |