Events

Rappel de Device Recall Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Arjo, Inc. dba ArjoHuntleigh.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58048
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1983-2011
  • Date de mise en oeuvre de l'événement
    2011-03-21
  • Date de publication de l'événement
    2011-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98101
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Lift, patient, non ac-powered - Product Code FSA
  • Cause
    The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.
  • Action
    ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Device

Device Recall Maxi Sky 1000 and BHM Medical V10 Bariatric Ceiling Lift
  • Modèle / numéro de série
    Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009. All serial numbers manufactured prior to February 1, 2011.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 || The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • Adresse du fabricant
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA