Events

Rappel de Device Recall Welch Allyn AED 20 Defibrillator

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
    39368
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1223-2007
  • Date de mise en oeuvre de l'événement
    2007-08-23
  • Date de publication de l'événement
    2007-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55297
  • 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
    Defibrillator - Product Code MKJ
  • Cause
    Failure to deliver therapy: the welch allyn aed20 defibrillators may display a "defib comm" error message on the device display during use which may result in failure of the device to analyze the patient's ecg and deliver the appropriate therapy.
  • Action
    On 8/23/07 the firm sent a press release to the Associated Press for release. On 8/29/07 the firm began sending URGENT MEDICAL DEVICE RECALL letters to their consignees informing them of the possibility of the defibrillator to fail to resuscitate the patient. The accounts were asked to respond to the notification within 5 working days by faxing or mailing an enclosed response. End users will be provided with a loaner device while their unit is being serviced. Distributors were sent a separate letter request they provide their customer names to the firm so that the firm can send letters to those customers.

Device

Device Recall Welch Allyn AED 20 Defibrillator
  • Modèle / numéro de série
    Serial number range - 205787 - 208907 (non-contiguous)   205787, 205788, 205789, 205790, 205791, 205793, 205794, 205795, 205796, 205797, 205798, 205799, 205800, 205801, 205802, 205803, 205804, 205805, 205807, 205808, 205809, 205810, 205811, 205812, 205813, 205814, 205815, 205816, 205817, 205818, 205819, 205820, 205821, 205822, 205823, 205824, 205825, 205826, 205827, 205828, 205829, 205830, 205831, 205832, 205833, 205834, 205835, 205836, 205837, 205838, 205839, 205840, 205841, 205842, 205843, 205844, 205845, 205846, 205847, 205848, 205849, 205850, 205851, 205852, 205853, 205854, 205855, 205856, 205857, 205858, 205860, 205861, 205862, 205863, 205864, 205865, 205866, 205867, 205868, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 205879, 205880, 205881, 205882, 205883, 205884, 205885, 205886, 205887, 205888, 205889, 205890, 205891, 205892, 205893, 205894, 205897, 205898, 205899, 205900, 205901, 205902, 205903, 205904, 205905, 205906, 205908, 205909, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.
  • Description du dispositif
    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)
  • 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