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

Model Number 1008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Heart Failure (2206)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received and evaluated.The reported problem was confirmed.Testing revealed that a pneumatic valve (igor valve) had failed which prevented the unit from functioning properly.The valve was replaced.Since this unit has been in service for eight years without the recommended factory service, a complete evaluation was done and recommended preventative service was performed.The unit was checked, tested to ts240 and returned to the customer.

Event Description

The device was applied to patients in cardiac arrest.It was reported that when the device was brought to the scene it would not function.The unit was removed from the patient and manual cardiopulmonary resuscitation was continued.The patient was not revived.

• 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: 7333562
• MDR Text Key: 102341026
• Report Number: 1821850-2017-00010
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Paramedic
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/03/2017

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: Physician
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 8 YR
• Initial Date Manufacturer Received: 07/20/2017
• 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: 57 YR
• Patient Weight: 90