Events

Rappel de Device Recall Model 134, WarmAir Convective Warming Device

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 Cincinnati Sub-Zero Products 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
    59018
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2800-2011
  • Date de mise en oeuvre de l'événement
    2011-05-19
  • Date de publication de l'événement
    2011-07-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100840
  • 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
    System, thermal regulating - Product Code DWJ
  • Cause
    A component defect. the recalling firm determined that one of the connectors attached to the firm's warmair 134 device's printed circuit board (pcb) can overheat. should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit.
  • Action
    CSZ Cincinnati Sub-Zero sent an "URGENT MEDICAL DEVICE RECALL FIELD ACTION" notice to all affected customers. The letter identifies the product, problem, and actions to be taken. CSZ instructs customers to complete and return an enclosed recall response form and to state whether or not their facility is in possession of the device. The completed form should be returned via fax at 513-772-9119 or via e-mail to WA134Recall2011@cszinc.com. Additionally, customers are instructed to discontinue use of the device and return to their Biomedical Engineering and/or Service Department for device exchange and return. Questions regarding this notice are directed to the WarmAir 134 field action (recall) administrator at 1-800-989-7373.

Device

Device Recall Model 134, WarmAir Convective Warming Device
  • Modèle / numéro de série
    Part #86180, Device Listing #D111865, Serial Numbers: 963-1340100 thru 964-1340199; 971-1340200 thru 971-1340294, 973-1340345 thru 973-1340455; 974-1340445 thru 974-1340594; 981-1340605 thru 981-1340674; 983-1340815 thru 983-1340864; 984-1340905 thru 984-1340964; 991-1341025 thru 991-1341064; 992-1341095 thru 992-1341174; 993-1341265 thru 993-1341274; 994-1341365 thru 994-1341374; 001-1341375 thru 001-1341404; 002-1341405 thru 002-1341414; 003-1341415 thru 003-1341424; and 004-1341425-2 thru 004-1341426-2, are subject to recall**.   **Please Note: CSZ serializes the WarmAir 134 devices beginning with the last two digits of the year manufactured, followed by the quarter of manufacture, the numbers "134" and then a sequential number. For example, a unit with serial number 963-1340100 was manufactured in the third quarter of 1996 with a sequential number of 0100.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the country of Canada.
  • Description du dispositif
    Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. The device draws in room air through a filter by means of an electric blower. It heats the air to the desired temperature by controlling the air temperature entering a flexible connecting hose, and conveys it to the disposable blanket (i.e. FilteredFlow Blankets, Warming Tube) in contact with the patient, in order to warm the patient. || This device provides a continuous flow of heated air as a means of warming patients suffering the common, but significant problems of hypothermia. The system can be used in Post Anesthesia Care Units (PACUs), Intensive Care Units (ICUs), Surgical Intensive Care Units (SICUs), Emergency Rooms (ERs), Operating Rooms (ORs), or any other departments or hospital facilities requiring patient temperature management.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Adresse du fabricant
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • Société-mère du fabricant (2017)
    Gentherm, Inc.
  • Source
    USFDA