MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, LLC THUMPER; EXTERNAL CARDIAC COMPRESSOR

Model Number 1007CC

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device received in fair condition.Customer complaint that the device would not adjust compression is confirmed.The knob is spinning around the cdnv stem and not allowing the compression depth to change.The set screw holding the knob to the stem had stripped out.Replaced cdnv knob with double set screw to prevent the knob from spinning freely.Cleaned and re-lubed piston dome.Checked.Tested, and accepted to ts234.The device was returned to the customer.

Event Description

It was reported that the device was being set up on a patient to perform cpr.It was reported the device's chest depth needle valve knob was spinning freely and not engaging the chest depth on the device.Device was removed from the patient and manual cpr was applied.The patient was not revived.

• Brand Name: THUMPER
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, LLC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer (Section G): MICHIGAN INSTRUMENTS, LLC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer Contact: chris blanker ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 8112350
• MDR Text Key: 129459697
• Report Number: 1821850-2018-00003
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 YR
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR