Events

Rappel de Device Recall Welch Allyn Vital Sign Monitor

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 Welch Allyn Protocol, 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
    52721
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1873-2009
  • Date de mise en oeuvre de l'événement
    2009-07-28
  • Date de publication de l'événement
    2009-07-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83814
  • 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
    Vital Sign Monitor - Product Code MWI
  • Cause
    The welch allyn vsm300 vital signs monitor may experience a loss of audio which includes a loss of audio alarms.
  • Action
    An "Urgent: Correction" letter dated July 28, 2009 was sent to customers describing the risk associated with loss of audible alarms and recommend that the users mitigate the risk by checking for proper audible alarm function each time they power on the device. (Current labeling describes the variety of beeps and tones that should be present). Users were instructed: 1) if the audio fails, do not use the device, 2) Remove it from service and 3) contact Welch Allyn Protocol, Inc. at the following telephone number (1-800-289-2501) to arrange the return and repair of your device to Technical Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.

Device

Device Recall Welch Allyn Vital Sign Monitor
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Bulgaria, Bahrain, Botswana, Canada, Switzerland, China, Cyprus, Germany, Denmark, Egypt, Spain, Figi, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Iceland, Italy, Jordan, Kenya, Kyrgyzstan, South Korea, Kuwait, Lebanon, Sri Lanka, Malaysia, Nigeria, The Netherlands, Norway, New Zealand, Oman, Phillipines, Pakistan, Poland, Puerto Rico, Panama, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Thailand, Taiwan and South Africa.
  • Description du dispositif
    Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). || The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA