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