FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 4077246
·
Received August 21, 2014
Report
- Report Number
- 3006697241-2014-00624
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- July 26, 2014
- Report Date
- July 26, 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
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE SIDECOM CABLE HAD BROKEN PINS. 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 PREVENTIVE ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SIDECOM COMMUNICATION BOARD 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 THE ACCOUNT STATING NURSE CALL IS NOT FUNCTIONING. THE BED WAS LOCATED AT THE ACCOUNT IN ENGINEERING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504785 | ADVANTA BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILLROM DE MEXICO S DE RL DE CV | 1190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |