Events

Rappel de Device Recall Fisher and Paykel Healthcare CosyCot and Kit Replacement Head

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 Fisher & Paykel Healthcare, Ltd..

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
    69668
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0210-2015
  • Date de mise en oeuvre de l'événement
    2014-11-06
  • Date de publication de l'événement
    2014-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131307
  • 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
    Warmer, infant radiant - Product Code FMT
  • Cause
    Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
  • Action
    Fisher & Paykel Healthcare sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Step 1: Identify any affected Infant Warmers in your inventory by checking the REF and SERIAL number on the device label (see examples in Figures 1 and 2). Step 2: Identify any affected spare parts in your inventory by checking the REF and LOT number on the parts (see example in Figure 3). Step 3: Check your Infant Warmer service records to determine if affected spare parts were installed on any other Infant Warmers. If you are unable to identify specific Infant Warmers that may have had affected spare parts installed, then please contact FPH at the contact details below. Step 4: Replacement of Affected Nut. - Remove the affected Infant Warmer from use. - Switch the warmer off and disconnect it from the mains power supply. - Support the heater head during disassembly to prevent it from falling. - Follow Steps A to F in Figure 4 below to replace the nut. - Ensure the pivot washer remains in place when installing the new nut. - Ensure that the heater head is secure, can rotate smoothly, and the detent locates the head in the central position. - Reconnect the mains power supply, switch the warmer on, and ensure there are no error codes or alarms before returning to use. Step 5: Complete the Urgent Medical Device Recall Response Form and return it to your FPH Representative

Device

Device Recall Fisher and Paykel Healthcare CosyCot and Kit Replacement Head
  • Modèle / numéro de série
    Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ  Spare Parts: 071116 - 090810
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.
  • Description du dispositif
    Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer || Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly || It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. || Infant Warmers Model Number (REF) || IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX || Spare Parts Model Number (REF) || 043041129, 043041130, 043041131, 043042359, 648040142
  • Manufacturer
    Fisher & Paykel Healthcare, Ltd.

Manufacturer

Fisher & Paykel Healthcare, Ltd.
  • Adresse du fabricant
    Fisher & Paykel Healthcare, Ltd., 15 Maurice Paykel Place, East Tamaki, Auckland New Zealand
  • Source
    USFDA