FDA Adverse Event
Death
Summary report: N
TRUSAT PULSE OXIMETER
MDR report key: 1999221
·
Received February 18, 2011
Report
- Report Number
- 9613557-2011-00008
- Event Type
- Death
- Date Received
- February 18, 2011
- Date of Event
- January 13, 2011
- Report Date
- February 18, 2011
- Manufacturer
- GE HEALTHCARE
- Product Code
- DPZ
- PMA / PMN Number
- K040831
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WHO WAS USING A TRUSAT PULSE OXIMETER IN A HOME ENVIRONMENT DIED IN HER SLEEP. THE PT'S MOTHER REPORTED THAT SHE REC'D AN URGENT MEDICAL DEVICE CORRECTION LETTER FOR THE TRUSAT SEVERAL DAYS AFTER HER DAUGHTER'S DEATH. THE PT HAD BEEN DIAGNOSED WITH RETT SYNDROME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUSAT PULSE OXIMETER | OXIMETER | DPZ | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Death |