Events

Recall of Thumper

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
    36313
  • Event Risk Class
    Class 3
  • Event Number
    Z-0178-2007
  • Event Initiated Date
    2006-09-14
  • Event Date Posted
    2006-11-14
  • 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=48402
  • 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
    Compression device - Product Code DRM
  • Reason
    Failure to initiate compressions when turned on.
  • Action
    The Japanese distributor is instructed by letter dated 9/14/06 to drill a small hole in the male checked connector at the base of the column in order to allow rapid bleed off of the pressure and to give customers a revised operators manual.

Device

Thumper
  • Model / Serial
    All units sold in Japan (All serial numbers with 7- or 9- followed by 4 numbers; e.g. 7-xxxx or 9-xxxx).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Japan.
  • Product Description
    Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.
  • 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