FDA Adverse Event
Other
Summary report: N
JACE SHOULDER CPU
MDR report key: 45828
·
Received October 24, 1996
Report
- Report Number
- 2246559-1996-00010
- Event Type
- Other
- Date Received
- October 24, 1996
- Date of Event
- October 22, 1996
- Report Date
- October 24, 1996
- Manufacturer
- JACE SYSTEMS
- Report Source
- Distributor report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT WAS SEATED IN A CHAIR MOUNTED SHOULDER CPM UNIT. HE PASSED OUT WHILE IN THE CHAIR. REP BRACED PT SO PT WOULDN'T HURT HIMSELF. PT'S TONGUE WENT TO THE BACK OF HIS HEAD. WIFE CALLED 911. AMBULANCE TOOK PT TO ER. PT WAS FOUND TO BE DEHYDRATED AND GIVEN FLUIDS. NO OTHER MEDICAL TREATMENT WAS PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JACE SHOULDER CPU | CHAIR MOUNTED SHOULDER | JACE SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |