FDA Adverse Event
Malfunction
Summary report: N
CS BED 9153650455
MDR report key: 4959541
·
Received August 3, 2015
Report
- Report Number
- 3003433498-2015-00131
- Event Type
- Malfunction
- Date Received
- August 3, 2015
- Report Date
- July 9, 2015
- Manufacturer
- CARROLL HEALTHCARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
A WELD BROKE ON THE FOOT SECTION OF THE DECK, NOT OUT OF BOX, NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504487 | CS BED 9153650455 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | CARROLL HEALTHCARE | IHCS9FX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |