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

Model Number 1008

Device Problem Loss of Power (1475)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of three incidents involving the same unit used for cardiopulmonary resuscitation.It was reused several times despite the fact that it did not function correctly.We received the following report from the user: "they received device monday and used device friday.After 3-4 minutes of use on patient the device suddenly stopped running and appeared to be stuck.The device was removed from patient.It was then brought to the lab and run on air for approximately 1 hour with no troubles.On saturday, the device was tried again on a patient with the same troubles that occurred friday.Once again, the device was brought to the lab and run for 15-20 minutes and found to be functional.The device was then tried on a patient sunday and once again failed to function during use." a technician was sent from the company and was able to verify the problem.User was told to stop using the device.And return it for evaluation.The unit has not yet been returned despite several requests.

Event Description

The device was applied to a patient that was pulseless and apneic in an attempt to resuscitate the patient.It was reported that after 8-10 minutes of use on the patient the device stopped running.This device was removed from the patient and cpr was continued with a second device.The patient was not revived.It was reported by the user that the failure of the device 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: 7333548
• MDR Text Key: 241266022
• Report Number: 1821850-2016-00003
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K972525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Paramedic
• Device Model Number: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• 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