FDA Adverse Event
Death
Summary report: N
INVACARE THERAPEUTIC SUPPORT SYSTEMS
MDR report key: 417840
·
Received September 18, 2002
Report
- Report Number
- 1525712-2002-00105
- Event Type
- Death
- Date Received
- September 18, 2002
- Date of Event
- August 21, 2002
- Report Date
- August 29, 2002
- Manufacturer
- INVACARE BEDS
- Product Code
- IKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
THE CONSUMER WAS LYING ON THEIR SIDE AND DOING FINE AT 6:30. AT 6:50, THE CONSUMER WAS ALLEGEDLY FOUND LAYING FACE DOWN IN THEIR PILLOW AND DEAD FROM APPARENT ASPHYXIATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE THERAPEUTIC SUPPORT SYSTEMS | 890.5225 | IKZ | INVACARE BEDS | BB9722000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death |