Agency classClass IIOur severity:High FDA (Devices)·Z-1794-2013·Announced 2013-07-31

Hill-Rom TotalCare Bed Recall Due to Mattress Egress Injury Risk

Hill-Rom is recalling 4,121 TotalCare Beds because the mattress may not stay flat in the chair egress position, creating a risk of patients falling or sliding to the floor.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Hill-Rom, Inc. is recalling 4,121 units of the TotalCare Bed System used with AccuMax Quantum VPC, Complete, and Convertible mattresses. The recall covers beds distributed worldwide, including the United States, Canada, Colombia, Nigeria, Kuwait, and Saudi Arabia. The affected mattresses were distributed between September 2005 and April 2013.

The recall is issued because when the bed is placed in the chair egress position, the magnets on the mattress may fail to hold the bottom of the mattress flat against the bed frame. This causes the foot section of the mattress to extend away from the bed at an angle. A patient attempting to return to the bed may miss the seat and sit on the foot section instead, potentially sliding down to the floor or falling, which could result in injury.

Health care facilities and consumers should stop using the affected TotalCare Bed Systems immediately. Hill-Rom, Inc. is the recalling firm and will provide instructions for the recall.

The recalled product

Product: TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System…
Manufacturer: Hill-Rom, Inc.
Category: Medical Device — Hospital Bed
Hazard: fall-injury
Affected units: 4,121

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

Bed model numbers: PAU001010784
PAU005010784
P1900
PAK169N10184
PAK169N10384
PA8171210184
PA8175210184
PA8175210384
PA8171210384
PA8171310384
and PA8173210384. The AccuMax Quantum VPC
Complete and Convertible mattresses are not serialized
but were distributed between September 2005 and April 2013

Distribution

Distributed nationwide across the United States.

Same manufacturer · Hill-Rom, Inc.

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