MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC LIFE-STAT; EXTERNAL CARDIAC COMPRESSOR

Model Number 1008

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Death (1802)

Event Date 01/09/2015

Event Type  No Answer Provided  

Event Description

The device was applied to a patient in cardiac arrest.Following the rescue attempt, the customer reported that the patient's chest had an imprint of the massaged pad and was bruised.Pictures received showed a mark centered on the patients chest with some indication of a bruise.This was located at the contact point of the pad performing chest compressions.The patient was not revived.

Manufacturer Narrative

A complete evaluation of this device was performed and no functional or performance issues were found.The photos that were sent did show that the patient was not properly secured with the straps.This would allow patient movement during cpr which may have contributed the mark left by the massager pad.

• Brand Name: LIFE-STAT
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, INC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer (Section G): MICHIGAN INSTRUMENTS, INC.; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer Contact: joe baldwin ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 4504537
• MDR Text Key: 19768957
• Report Number: 1821850-2015-00002
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Type of Report: Initial
• Report Date: 02/10/2015

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: Emergency Medical Technician
• Device Model Number: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2013
• 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: 35 YR
• Patient Weight: 70