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

Model Number 1008

Device Problems Crack (1135); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The device was applied to a patient in cardiac arrest.Before the proper compression depth was attained, the base plate of the device made a cracking noise and broke.The device was removed from the patient and manual cpr was continued.The patient was not revived.It was reported by (b)(6) that the failure of the device did not contribute to the death of the patient.

Manufacturer Narrative

A new base was supplied to the user.The base design for this device has been in use continually for the past sixteen years.A broken base is a very unusual occurrence but has occured several times with this particular ems service.As a result representatives were sent to meet with these users to try to determine if the device is being used and handled properly.Extensive testing was also done on the base to determine if some factor, such as materials or manufacturing process has changed and is contributing to this problem.Testing and evaluation concluded that although possible to break a base, it requires forces that should not be present during normal use.In addition, we have started the process of increasing the strength of the base by using a stronger material and a mold change.

• 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: joe baldwin ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 4291466
• MDR Text Key: 5191320
• Report Number: 1821850-2014-00007
• 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 Facility
• Reporter Occupation: Paramedic
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 MO
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2013
• 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: 60 YR
• Patient Weight: 82