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

Model Number 1007CC

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to the manufacturer for evaluation.End user was sent a replacement base and reported that it attaches properly with the arm/column assembly.

Event Description

When attempting to perform mechanical cpr to the patient, within the first few compressions, the arm/column assembly disconnected from the base.It was noted the support pin on the base was bent and the arm/column assembly could not be re-connected.

• 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: 9566048
• MDR Text Key: 198597737
• Report Number: 1821850-2020-00001
• 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: Other
• Type of Report: Initial
• Report Date: 01/08/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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: 25 YR
• Patient Weight: 147