Events

Avis De Sécurité sur ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par ArjoHuntleigh.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2012(15)
  • Date
    2012-09-06
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/arjohuntleigh-passive-patient-lifts-and-ceiling-lifts-with-four-point-hanger-bars-intended-for-use-with-passive-clip-slings-and-clip-flite-slings&id=887df825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Arjohuntleigh’s complaint trending has shown a number of events relating to clip detachments. analysis and investigation of the root cause of these reported events has shown that non-attachment or incorrect attachment of the clip has been a main cause of what has been perceived as detachments. if the sling clips are not applied or are not applied correctly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.  arjohuntleigh have been unsuccessful in their attempts to date to locate all devices in ireland affected by this field safety corrective action. this alert applies to any users of arjohuntleigh passive patient lifts and ceiling lifts on the irish market that have not previously carried out this recommended action.
  • Action
    The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected lifts.  3. If you / your institution have affected lifts, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that the corrective action is completed on all affected medical devices.

Device

ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for us...
  • Modèle / numéro de série
  • Description du dispositif
    ArjoHuntleigh Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with Passive Clip Slings and Clip Flite Slings
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HPRA