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

Model Number 1008

Device Problem Mechanical Problem (1384)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to the manufacturer for evaluation.Distributor evaluated the device, testing it 8 times ranging from 15 minutes to 70 minutes per test session, and were unable to duplicate the reported problem.

Event Description

The user reported that under 30:2 mode, the compression piston would not go up when it was ventilated.

• 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: 9287967
• MDR Text Key: 203127170
• Report Number: 1821850-2019-00003
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1008
• Device Catalogue Number: 16000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: 50 YR
• Patient Weight: 55