Events

Retiro De Equipo (Recall) de Device Recall Penner Patient Transfer/Lift System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Penner Mfg Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56977
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1911-2011
  • Fecha de inicio del evento
    2009-01-19
  • Fecha de publicación del evento
    2011-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95097
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lift, patient, ac-powered - Product Code FNG
  • Causa
    Incomplete weld on the pillar mounting bracket.
  • Acción
    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
  • Modelo / Serial
    Model 380000-1 - Serial numbers 08020346201, 8020346203, 10020360901, 10020360902, 10020360903, and 08020346202;  Model 380000-2 - Serial numbers 08020346201, 08020346203, and 11020367501.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Canada and Mexico.
  • Descripción del producto
    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
  • Dirección del fabricante
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA