Events

Recall of Thumper mechanical cardiopulmonary resuscitator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Michigan Instruments, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35934
  • Event Risk Class
    Class 3
  • Event Number
    Z-0119-2007
  • Event Initiated Date
    2006-08-04
  • Event Date Posted
    2006-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47197
  • Notes / Alerts
    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.
  • Extra notes in the data
    mechanical cardiopulmonary resuscitator - Product Code DRM
  • Reason
    Failure to initiate compressions when first turned on, if improperly shut down-operator manual updated to include proper shut down procedures.
  • Action
    Consignees were sent a letter dated 8/4/06 with additional instructions for use. A second letter was sent on 9/1/06 to correct the new instructions provided in the first letter for page 19 of the instructions.

Device

Thumper mechanical cardiopulmonary resuscitator
  • Model / Serial
    All units with a manual configuration (as opposed to a pneumatic configuration).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide- USA and countries of Brazil, Canada, China, Germany, Greece, Japan, Korea, Macau, Netherlands, Pakistan, Spain, Taiwan and United Kingdom.
  • Product Description
    Michigan Instruments Thumper Mechanical CPR Device; Model 1007.
  • Manufacturer
    Michigan Instruments, Inc.

Manufacturer

Michigan Instruments, Inc.
  • Manufacturer Address
    Michigan Instruments, Inc., 4717 Talon Court S.E., Grand Rapids MI 49512-5408
  • Source
    USFDA