Events

Rappel de Device Recall ArjoHuntleigh

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 ARJOHUNTLEIGH POLSKA Sp. z.o.o..

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
    68594
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2693-2014
  • Date de mise en oeuvre de l'événement
    2014-07-28
  • Date de publication de l'événement
    2014-09-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128286
  • 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
    Arjohuntleigh received three reports where the bolt under the scale unscrewed from the scale. there is a remote risk concerning the bolt unscrewing from the scale. when the scale and bolt parts are not correctly serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. as a result, the sp.
  • Action
    ARJOHUNTLEIGH sent an URGENT - FIELD SAFETY NOTICE letter dated July 28, 2014 to all customers. The letter identified the affected product, problem and actions to be taken. The letters provided customers with two options with how to address this recall: 1) because the devices are close to their 10-year lifetime, customers can return the devices for a trade-in discount that will be applied to the purchase of a new ArjoHuntleigh patient transfer lift; or 2) an ArjoHuntleigh Service Technician will install a new scale with added locking features to the existing unit free of charge. Customers were further instructed to: 1) ensure that all caregivers and users of the devices are given a copy of the letter; 2) place a copy of this letter with the device's instruction for use; and, 3) to complete and return the enclosed Customer Service Response form. For questions or assistance completing the Customer Response Form, please contact ArjoHuntleigh at 1-800-323-1245, ext. 57985 during office hours; Monday to Friday, 8:00am to 5:00pm (CST) or via email at AHNA-RA@arjohuntleigh.com.

Device

Device Recall ArjoHuntleigh
  • Modèle / numéro de série
    Model Numbers: HMA0002 and HMB002-US;  Serial Numbers: MPLAT0409W1177 ; MPLAT0410W1213 ; MPLAT0410W1228 ; MPLAT0410W1229 ; MPLAT0410W1231 ; MPLAT0410W1232 ; MPLAT0412W1290 ; MPLAT0412W1296 ; MPLAT0412W1297 ; MPLAT0502W1403 ; MPLAT0502W1404 ; MPLAT0503W1485 ; MPLAT0503W1486 ; MPLAT0504W1518 ; MPLAT0504W1519 ; MPLAT0504W1520 ; MPLAT0504W1531
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the state of MA and the countries of Australia, Germany, and Italy.
  • Description du dispositif
    Minstrel (with scale) || Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is accomplished by placing a sling under the patient, and attaching the sling to a spreader bar that is connected to a lifting arm jig via a connection to the spreader bar that allows a swiveling up-down movement. Using battery power, an actuator then powers the lifting arm upwards so that the patient in the sling is lifted from, typically, a bed or chair.
  • Manufacturer
    ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Manufacturer

ARJOHUNTLEIGH POLSKA Sp. z.o.o.
  • Adresse du fabricant
    ARJOHUNTLEIGH POLSKA Sp. z.o.o., UI. KS. PIOTRA WAWRZYNIAKA 2, KOMORNIKI Poland
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA