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

Model Number 1008

Device Problem Device Stops Intermittently (1599)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 04/16/2017

Event Type  malfunction  

Manufacturer Narrative

This failure was reported to us by the distributor.The user stated that this problem has happened several times.However, the device has not been returned for evaluation.We have, therefore, not been able to examine or test the unit to confirm the problem or determine the reason for the unit stopping.The device is currently in service.

Event Description

The device was applied to patients in cardiac arrest.It was reported that after ten - thirty minutes of use the unit would suddenly stop.This occured several times, but the unit was able to restart after being put away for awhile.In each case the unit was removed from the patient and manual cardiopulmonary resuscitation was continued.The patient was not revived.The user stated that the failure did not contribute to the death of the patient.

• 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: jim maatman ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 7333556
• MDR Text Key: 241265996
• Report Number: 1821850-2017-00009
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 YR
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0
• Patient Age: 58 YR
• Patient Weight: 53