Events

Recall of Device Recall Progressa Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79516
  • Event Risk Class
    Class 2
  • Event Number
    Z-1319-2018
  • Event Initiated Date
    2018-01-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162541
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Reason
    A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.
  • Action
    Firm has developed a correction for the braking system and plan to have a Hill-Rom technician to update affected Progressa Beds. Hill-Rom sent a letter, dated January 12, 2018. Until beds are updated, follow the safety information as outlined in the Progressa User manual each time when setting 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 moving a patient 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 following the instructions above, take the bed out of service until the bed is updated.

Device

Device Recall Progressa Bed
  • Model / Serial
    S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.
  • Product Description
    Progressa Bed - AC-powered adjustable hospital bed
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA