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

Model Number 1008

Device Problem Loss of Power (1475)

Patient Problem Heart Failure (2206)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

This device arrived in generally good condition.However, when the device was turned on the low battery indicator was lit and the device did power up but shut down shortly after.When an attempt was made to start the device again the battery light indicated that there was not enough battery power left to use the device.The voltage of the batteries was checked, battery #1 at 6.34 v and #2 at 6.44 v.The batteries were removed and the device was powered up using a continuous power supply.The device powered up as normal and ran with no issues.Ran device on new 9 volt batteries for approximately 20 minutes with no trouble.A complete evaluation and check out was completed and the unit runs to its' specifications.The unit was returned to the customer with new 9 volt batteries.

Event Description

The device was applied to a patient and performing cardiopulmonary resuscitation.It was reported that after 2 hours the unit stopped.The device was removed from the patient and manual cpr was continued.

• 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: 7333549
• MDR Text Key: 102325289
• Report Number: 1821850-2016-00006
• 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: 10/31/2016

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: 16000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 1
• Patient Age: 95 YR