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

Model Number 1007CC

Device Problems Device Inoperable (1663); Failure to Shut Off (2939)

Patient Problem Heart Failure (2206)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device arrived in good condition.There were no signs of any damage to the device.The customer complaint that the device would not shut off could not be confirmed.Upon the initial evaluation the compressor could be heard turning on and off when the switch was turned.When the depth compression knob the device began to compress, the on/off switch was turned to off and the compression stopped.The front cover was taken off the device to examine the on/off switch but there is no damage to the assembly.Long term testing was not able to reproduce the complaint.Unit was returned to the customer.

Event Description

It was reported that the device was used to perform cpr on a patient for about 30 minutes.The patient was not revived but when attempting to remove the device, it would not shut off.The oxygen hose was disconnected which stopped the unit.It was stated that the problem did not contribute to the failure to revive the patient.

• 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: 7333564
• MDR Text Key: 102458461
• Report Number: 1821850-2017-00013
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00860682000107
• UDI-Public: (01)00860682000107(11)160928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/01/2017

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: Paramedic
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Initial Date Manufacturer Received: 10/16/2017
• 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