FDA Adverse Event
Malfunction
Summary report: N
CCU WITH SCALE BED
MDR report key: 3112225
·
Received May 3, 2013
Report
- Report Number
- 1824206-2013-02465
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BRAKE IS NOT HOLDING. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193627 | CCU WITH SCALE BED | A/C POWERD ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |