FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 2984563
·
Received February 28, 2013
Report
- Report Number
- 3003433498-2013-00130
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Report Date
- February 4, 2013
- Manufacturer
- CARROLL HEALTHCARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(6) THE DEALER REPORTED THAT THE IHCS7 CARROLL HEALTHCARE BED HAD THE FOOT AND KNEE DECK WELD BROKEN. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85736 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | CARROLL HEALTHCARE | IHCS7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |