FDA Adverse Event
Malfunction
Summary report: N
ADVANTA 2 BED
MDR report key: 3812567
·
Received April 17, 2014
Report
- Report Number
- 3006697241-2014-00364
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 21, 2014
- Report Date
- March 21, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE SIDECOM COMMUNICATION CABLE NOT WORKING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THAT THE BED IS NOT COMMUNICATING WITH THE NURSES STATION. THE BED WAS LOCATED AT THE ACCOUNT IN ENGINEERING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORTED WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236131 | 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 |