FDA Adverse Event
Malfunction
Summary report: N
ADVANTA
MDR report key: 3893533
·
Received February 14, 2014
Report
- Report Number
- 1824206-2014-00445
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 17, 2014
- Report Date
- January 17, 2014
- Manufacturer
- HILL-ROM INC
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HILL-ROM SERVICE TECHNICIAN INSPECTED THE BED AND FOUND PATIENT LEFT HEAD SIDE RAIL WAS STUCK IN DOWN POSITION DUE TO THE SLIDE BRACKET BEING BENT. THE TECHNICIAN REPLACED SLIDE BRACKET ON PATIENT LEFT HEAD SIDE RAIL UNIT WORKING PROPERLY. THE MOST PROBABLE CAUSE FOR THE BENT SLIDE BRACKET IS MECHANICAL DAMAGE. NO FURTHER ACTION REQUIRED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWS THE LAST PREVENTIVE MAINTENANCE WAS (B)(4) 2013.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING PATIENT LEFT HEAD SIDE RAIL STUCK IN DOWN POSITION. THERE WAS NO PATIENT/USE 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 |
|---|---|---|---|---|---|---|---|
| 98914 | ADVANTA | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC | P1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |