Events

Rappel de Device Recall Penner Patient Transfer/Lift System

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 Penner Mfg 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
    56977
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1911-2011
  • Date de mise en oeuvre de l'événement
    2009-01-19
  • Date de publication de l'événement
    2011-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95097
  • 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, ac-powered - Product Code FNG
  • Cause
    Incomplete weld on the pillar mounting bracket.
  • Action
    The firm, Penner, sent an undated letter flagged "Important Safety Inspection: Action Required" via certified mail on January 19, 2009 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect the Penner Patient Transfer for any missing Welds of the Pillar Mounting Bracket; inspect the areas indicated in the enclosed photos to confirm the bracket is welded on all edges to the main frame of the base; complete the inspection, and complete and return the attached WELD INSPECTION RESULTS OF PENNER PATIENT TRANSFER form via fax to 402 694-5844 or mail to Penner Manufacturing Inc, 102 Grant Street, Aurora, NE 68818, Attn: Quality Assurance Manager. Penner stated in the letter, if welds are not complete (no weld), discontinue use and contact the Quality Assurance Manager at Penner Manufacturing immediately at 402-694-5003. If you have any questions, contact the Quality Assurance Manager at 402-694-5003.

Device

Device Recall Penner Patient Transfer/Lift System
  • Modèle / numéro de série
    Model 380000-1 - Serial numbers 08020346201, 8020346203, 10020360901, 10020360902, 10020360903, and 08020346202;  Model 380000-2 - Serial numbers 08020346201, 08020346203, and 11020367501.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada and Mexico.
  • Description du dispositif
    Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. || For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
  • Manufacturer
    Penner Mfg Inc

Manufacturer

Penner Mfg Inc
  • Adresse du fabricant
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA