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

Model Number 1008

Device Problem Device Stops Intermittently (1599)

Patient Problem Heart Failure (2206)

Event Date 05/10/2017

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

This failure was reported to us by the distributor.Although the user has stated this has happened several times, the device was not returned to us for evaluation.We have, therefore, not been able examine the unit to determine the reason for it's stopping.The device is currently in service.

• 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: 7333571
• MDR Text Key: 102583872
• Report Number: 1821850-2017-00006
• 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: 06/22/2017

1 Device was Involved in the Event

1 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: Emergency Medical Technician
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• 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: 1
• Patient Age: 68 YR
• Patient Weight: 67