Flamingo Hoist Causes Elderly And Disabled To "Drop To The Floor"

Main Category: Seniors / Aging
Also Included In: Medical Devices / Diagnostics
Article Date: 18 Jun 2009 - 5:00 PDT

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A hoist used in healthcare facilities as well as private homes across the country could cause an elderly or disabled person to "drop to the floor" risking death or serious injury according to a Field Safety Notice (FSN) issued by the manufacturer.

The old design of the spreader bar on the Flamingo mobile hoist could be incorrectly attached via an open hook and therefore come off the hoist jib as it lifts the occupant. The new design removes this possibility by attaching the bar with a karabiner.

Device experts at the Medicines and Healthcare products Regulatory Agency (MHRA) are concerned at the lack of response to the repeated publication of the FSN that urges users to have the spreader bar replaced.

Originally published in 2004 by the manufacturer, Invacare Ltd, the FSN was re-issued in 2006 and again in February 2009, yet less than half the hoists known to have been supplied in the UK have been changed.

The MHRA has also taken action in an attempt to raise awareness of the urgency of having the spreader bar replaced by issuing a Medical Device Alert (MDA). The alert informed users in the UK of the dangers of continuing to use the old design and gave details of how to arrange the necessary replacement.

MHRA Director of Device Technology and Safety, Clive Bray, said there have been no deaths or serious injuries reported in the United Kingdom as a result of the faulty hoist, however, there have been two fatalities reported in Sweden.

"I can't express strongly enough how important it is for people using a hoist with the old design of spreader bar to take it out of action immediately and arrange a replacement.

"The manufacturer, Invacare, is offering a free replacement, so please, don't put lives at risk by continuing to use these devices. Contact Invacare as soon as possible and arrange to have the required replacement spreader bar issued."

Users can contact Invacare UK Operations on 01656 647 327 to obtain replacement spreader bars with fitting instructions.

Notes

1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

2. People can contact Invacare UK Operations on 01656 647327 to obtain replacement spreader bars with fitting instructions.

3. The Medical Device Alert (MDA/2007/043) can be found on the MHRA website: Invacare Flamingo mobile patient hoists

4. A further advice issued in 2009 can be found on the MHRA website: Hoists, electrical: electrical hoist - Invacare UK Operations Ltd - Flamingo

5. 273 of the old design were sold in the UK with only 105 having been replaced.

Source
MHRA

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