FDA Adverse Event
Death
Summary report: N
INFORMATION CENTER NETWORK DATABASE
MDR report key: 1689099
·
Received May 10, 2010
Report
- Report Number
- 1218950-2010-00669
- Event Type
- Death
- Date Received
- May 10, 2010
- Date of Event
- May 2, 2010
- Report Date
- May 3, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K011093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT UPON A PATIENT DEATH, IT IS UNCLEAR IF THE ALARM CHAIN WORKED AS INTENDED. THE CUSTOMER WAS CALLING TO REQUEST ASSISTANCE IN VERIFICATION THAT THE CENTRAL STATION CORRECTLY SENT A MONITORING ALARM. 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. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT UPON A PATIENT DEATH, IT IS UNCLEAR IF THE ALARM CHAIN WORKED AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFORMATION CENTER NETWORK DATABASE | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3155B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |