FDA Adverse Event
Death
Summary report: N
PHILIPS INFORMATION CENTER
MDR report key: 1747743
·
Received June 29, 2010
Report
- Report Number
- 1218950-2010-01046
- Event Type
- Death
- Date Received
- June 29, 2010
- Date of Event
- June 26, 2010
- Report Date
- June 26, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K011093
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM FOR A PT WHO WENT INTO VTACH. THIS PT SUBSEQUENTLY EXPIRED. NO FURTHER INFO HAS BEEN RECEIVED BY PHILIPS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 THERE WAS A FAILURE TO ALARM FOR A PT WHO WENT INTO VTACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS INFORMATION CENTER | MHX, DRT | MHX | PHILIPS MEDICAL SYSTEMS | M3150B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death |