Events

Rappel de Device Recall Stanley BedCheck 30Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010

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 Stanley Security Solutions, 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
    57987
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1860-2011
  • Date de mise en oeuvre de l'événement
    2009-11-25
  • Date de publication de l'événement
    2011-03-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97933
  • 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
    Monitor, bed patient - Product Code KMI
  • Cause
    The cord could come loose from the mat potentially causing a short to the internal wiring.
  • Action
    The firm, Stanley Healthcare Solutions, issued an "Important Technical Bulletin" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a "Compliance Notice" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to obtain a return authorization number and take immediate action to return the units to the firms location in Lincoln, Nebraska. The Compliance Notice informed the customers who had not sent in their units to promptly read the notice and take the necessary steps to respond appropriately for their facility. Additionally, the customers were instructed to complete and return the Bed Check Sensormat Return Form and page 2 of the "Compliance Notice" via at 402-475-4281 or mail to: Compliance Engineer, Stanley Security Solutions, Inc., 1550 N. 20th Circle, Lincoln, NE 68503. Follow-up phone calls to nonresponders were made using a phone script. A "Second Notice Compliance Notice" dated October 20, 2010 was issued via certified mail to customers asking for immediate response to the previous communication. In addition, a third notice dated October 28, 2010 which was also flagged as "Second Notice" was again used asking for a response from the customers. If you have any questions regarding the notice or any action that may need to be taken by you, please contact Quality Manager at 1-800-824-2996 extension 3419 or Compliance Officers at 402-742-9414 or 402-742-9425.

Device

Device Recall Stanley BedCheck 30Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010
  • Modèle / numéro de série
    Lot numbers A1009, B1009, A0809, B0809, A0609, B0609, A0409, and B0409.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and the country of Canada.
  • Description du dispositif
    Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. || For use in reducing patient falls.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Adresse du fabricant
    Stanley Security Solutions, Inc., 1550 N 20th Cir, Lincoln NE 68503-1101
  • Société-mère du fabricant (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA