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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 040 03 18 000
Date submitted:	3/8/2018

Manufacturer:	Hill Rom Inc.
Device Type:	Progressa Bed Systems
Description:	Beds, Electric
Medical Device Identifier:	Affected devices: Progressa® Bed Systems P7500 Serial Numbers: S159AW9192 through S305AW2321 Production Dates: June 8, 2017 to November 1, 2017
Reason of Field Safety Corrective Action:	Brake Pedals May Fail, Potentially Allowing Unwanted Bed Movement and Leading to Patient Injury.
Remedy Action:	The firm has developed a correction for the braking system and will contact your facility to arrange for a Hill-Rom representative to update your systems on site. Until affected systems are updated, continue to adhere to the following safety information outlined in the Progressa user manual each time you set the brakes: Warning: Always set the brakes when the bed is occupied, except during patient transport. To help make sure the bed will not move, push and pull on the bed to check it after the brakes are engaged. Brakes should always be set when the bed is occupied and especially when a patient is moved from one surface to another. Patients often use the bed for support when getting out of bed and could be injured if the bed unexpectedly moves. After setting the brakes, push and pull the bed to make sure of stability." If the brakes do not hold after the above instructions are implemented, take the bed out of service until it is updated. Notify all relevant personnel at your facility of the information in the Urgent Medical Device Correction letter, and forward a copy of the letter to any facility
Athorized Representative/Importer/Distributor:	Medical regulations gate
Report Source:	NCMDR
Source Ref. Number:	46F67223A8279
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Hill-Rom Co. FSN.pdf

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