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MHRA and Manufacturers Safety Notices

Medicines and Healthcare Regulatory Agency

 

Oxford patient hoist weigh scales, part no. OP97000, supplied by Sunrise Medical or Joerns Healthcare (MDA/2011/006)
19/01/11
Medical Device Alert has been issued because the weigh scales on models supplied between July 1997 and April 2003 may detach from the hoist during a lifting operation, resulting in serious injury to the occupant or others.
   
Smart Chargers for Neptune, Aquila and Splash bath lifts and Solo toilet lifts
12/10/10
Smart Chargers for Neptune, Aquila and Splash bath lifts and Solo toilet lifts manufactured by Mountway (MDA/2010/079)
   
Atlantic bed rails
12/10/10
Atlantic bed rails, product code EBA013, manufactured by Park House Healthcare Ltd (MDA/2010/080)
   
Arjo Minstrel standard type HMA001 and EPC type HMA0011 manufactured by Medibo Medical NV.              13/04/10Inaccurate maintenance instructions and poor inspection of hanger bar attachment. Attachments have failed in use leading to a fall and injury to the person being moved.
   
Mobile electric patient hoists - various manufacturers.              18/04/10Potential for electric actuators to fail without warning, causing sudden dropping of the hoist
boom, leading to the serious injury of the patient and/or carer.
   
Hoists and Standaids manufactured by BHM Medical Inc.              10/03/10Risk of electric shock when the hoist is
connected to the mains supply with a single
insulated power cable for battery charging.
   
All models of mobile hoists, ceiling hoists and bathing lifts manufactured by Joerns Healthcare Ltd.              09/03/10Lack of maintenance and inspection of these devices could lead to the occupant falling and being seriously injured.
   
All types of Oxford slings and standing harnesses manufactured by Joerns Healthcare Ltd for use with hoists and stand aids.              09/03/10Unclear instructions for use. The MHRA has received various incident reports where occupants have been injured as a result of incorrect use or inadequate inspections of slings before use.
   
Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo.              18/02/10Incorrect attachment of the sling clips to the spreader bar. This can lead to the person in the sling falling out and injuring themselves or others.
   
C-Max U/2 stair climbers manufactured by Alber Antriebstechnik GmbH (AAT)                01/02/10There is a risk of injury to the attendant's hand, by the climbing mechanism, if the stair climber is activated when two people are moving it.
   
Action 3 and Action 4 manual wheelchairs manufactured by Invacare.              11/01/10             Users who are unaware of these revised instructions are at risk of injury. In particular, from a fall due to instability or from positional asphyxiation due to poor lap belt position, fitting or adjustment.
   
All types of bed mattresses              05/01/10If mattress covers are damaged, body or other fluids can pass through and contaminate the inner core.

 

MHRA and Manufacturers Safety Notices 2009

 

MHRA and Manufacturers Safety Notices 2008

 

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