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MHRA and Manufacturers Safety Notices

Medicines and Healthcare Regulatory Agency

 

   
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.
   
Birdie mobile hoists manufactured by Invacare.               14/12/09The legs of the base can detach and cause the hoist to tip in use, leading to injury to the occupant or others.
   
Rea Azalea wheelchairs manufactured by Invacare Rea AB.              14/12/09There are two problems which can cause the occupant to fall from the wheelchair and sustain a serious injury: 1.the backrest can fail in use
2.the posture belt can loosen if fitted or adjusted incorrectly.
   
Oxford slings - all types              11/11/09Guidance for correct usage information                                                                                                                                                 
   
Adapters used to attach Liko Scale weighing systems to patient hoists,manufactured by Liko              05/11/09Adapters that connect the weighing scale to the hoist can fail in use, resulting in a fall and serious injury to the occupant.
   
OXFORD Mermaid & Historic Oxford Hoists manufactured by Joerns Healthcare              02/11/09On 8th September 2008 a Field Safety Notice was issued on the correct use of the battery charger for the Oxford Mermaid and Historic Oxford Hoists.
   
OXFORD Mobile Hoists, Ceiling Hoists and Bathing Products, manufactured by Joerns Healthcare               02/11/09There have been a number of reported incidents of spreader bar detachments on older products, due to a lack of adequate inspection and competent maintenance.
   
Battery chargers supplied with Aquila and Neptune bath lifts manufactured by Mountway Ltd.               26/10/09The surface of the battery charger can get excessively hot in use. There is potential for injury if the unit is touched, especially for those with low skin sensitivity or poor circulation.
   
Escape 338S/SN Lite manual wheelchair.
Manufactured by Days Healthcare Ltd.
             22/10/09 Contrary to information in the original instructions for use, this model of wheelchair is not suitable for use as a seat in a motor vehicle. The wheelchair could fail in a vehicle impact, leading to injury of the wheelchair occupant or others.
                                                            Summary
Rea Assist wheelchairs manufactured by Invacare Rea AB.              08/10/09Due to an ineffective locking mechanism the backrest may suddenly detach and cause the user to fall from the wheelchair, resulting in serious injury.
   
Smart Mobile Hoists Manufactured by Molift              20/08/09Safety concerns over the collapse of Smart mobile hoists.
   
All University bath hoists manufactured by Unihoist Ltd              29/07/09If the seat is used without a safety belt there is a risk that the occupant slides out of the seat and sustains a serious injury.
   
Hospital beds. Eleganza Standard, Smart and Deluxe supplied by Pegasus or Linet.                 29/07/09Reminder that the emergency backrest release function on these beds may fail or become stiff and difficult to operate. This could lead to a delay in performing CPR.
   
Invacare Flamingo Hoist                 17/06/09could cause an elderly or disabled person to "drop to the floor" risking death or serious injury
   
Jazzy, Quantum and LX powered wheelchairs manufactured by Pride Mobility Ltd                16/02/09Safety concerns over wheelchair when being used as a seat in a motor vehicle
   
Mermaid, Dipper and Ranger bath hoists manufactured
06/11/08
Risk of a fall from the hoist resulting in serious injury or death due to lack of safety belt.
   
Alternating air mattress pumps
07/10/08
Alternating air mattress pumps models PHP198, 396, 398 and 399 supplied by Park House. Failure of timer mechanisms leading to the loss of pressure relief.
   
Access & Accent
07/10/08
Access and Accent attendant propelled wheelchairs manufactured by Remploy Healthcare. Rear tie-down location brackets not fitted.
   
Carendo  Multi-purpose HygieneChair
04/08/08
Carendo multi-purpose hygiene chair manufactured by Arjo.Risk of entrapment. 
   
Medi-Tec Classichoist
30/07/08
Medi-Tec Classic hoist manufactured by Aidservice Ltd. Risk of spreader bar becoming detached in use and dropping the hoist occupant.
   
Wheelchair
26/06/08
Action manual wheelchair with fixed back and height adjustable push handles manufactured by Invacare - MDA/2008/044
   
Seat Belt Alert
05/06/08
Inappropriate or incorrectly fitted posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs could be fatal warns medical devices regulator
   
Potential for electric hoists to fail              18/04/05Potential 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.

 

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