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

Model Number 1008

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Distributor replaced timing regulator.Device was tested to final test specifications and returned to customer.

Event Description

Reported by head nurse that the device had stopped compressions during operation several times.

• 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: 12699662
• MDR Text Key: 282737788
• Report Number: 1821850-2021-00004
• 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: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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