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

Model Number 1008

Device Problem Device Inoperable (1663)

Patient Problem Heart Failure (2206)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device arrived in good condition.The customer complaint of no compressions was confirmed, as well as the sound of leaking air.There was a noticable rattle coming from inside the covers.The unit arrived with no lip valve or pdv cover and the screw for the arm lock handle was also missing.The covers were removed to evaluate the rattling noise and it was discovered that a blank hose fitting from the cdnv valve had loosened and come out of its fixture.This allowed all of the gas to escape before enterring the system causing the failure to compress.The fitting was replaced and the device functioned properly to all of its' specifications.

Event Description

The device was applied to a female patient in cardiac arrest.It was reported that the unit was in use for well over 20 minutes without any complications or issues.Without any notice the unit stopped compressing.The operators checked batteries and connections but were not able to get the unit to work.The unit was removed from the patient and manual cpr was continued.It is not known if the patient was ultimately 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: 7333558
• MDR Text Key: 102340616
• Report Number: 1821850-2017-00001
• 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: health professional,user faci
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/09/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Date Manufacturer Received: 04/19/2017
• 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