Events

Rappel de Device Recall Nautica (GK) Mattress Stretcher

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..

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
    46383
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1234-2008
  • Date de mise en oeuvre de l'événement
    2007-01-23
  • Date de publication de l'événement
    2008-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67340
  • 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
    Non-AC powered patient lift - Product Code FSA
  • Cause
    Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. this would allow the backrest to pivot freely down to the floor.
  • Action
    BHM Medical initially notified the end users on 1/23/07 of the potential for the back and leg rest latch ratchets to become damaged, allowing the rests to pivot freely. Should a patient be in the stretcher at the time, the patient could fall, potentially sustaining cuts, bruises or even more severe injuries. The letters provided safety instructions to follow until a permanent fix is available, and requested the accounts to complete and return the enclosed response form acknowledging receipt of the letter and dissemination of the safety instructions to all employees operating the lifts with the affected GK stretchers. BHM sent Customer Field Correction Notification letters dated 1/23/08 to the accounts, along with the Technical Advisory Notice - TAN A dated 1/3/08, reiterating the safety instructions from the 1/23/07 letter and requesting the accounts to, if at all possible, remove the equipment from service until an authorized engineer can replace the ratchets in the backrest and leg rest latches. All consignees have been contacted.

Device

Device Recall Nautica (GK) Mattress Stretcher
  • Modèle / numéro de série
    There are no serial numbers on the GK Mattress Stretchers. The following bath lifts have the affected stretchers: BHM Part Number 88004051, serial number NTCA-040; BHM Part Number 88004051.12, serial numbers NTCA-0197, NTCA-0200, NTCA-0201, NTCA-0225, NTCA-0166, NTCA-0198
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas.
  • Description du dispositif
    Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Adresse du fabricant
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA