FDA Adverse Event
Malfunction
Summary report: N
ADVANTA 2 BED
MDR report key: 3883816
·
Received February 13, 2014
Report
- Report Number
- 3006697241-2014-00142
- Event Type
- Malfunction
- Date Received
- February 13, 2014
- Date of Event
- January 15, 2014
- Report Date
- January 15, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE COMMUNICATION CABLE WAS NOT PROPERLY SEATED IN THE BOARD. THE TECH RESEATED AND ATTACHED THE COMMUNICATION CABLE TO THE SIDECOM BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE NURSE CALL WAS NOT FUNCTIONING FROM THE SIDE RAILS. THE BED IS LOCATED IN THE STORAGE AREA OF THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96653 | ADVANTA 2 BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILLROM DE MEXICO S DE RL DE CV | 1190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |