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

Model Number	1007CC
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, INC; 4717 talon ct. se; grand rapids MI 49512
• MDR Report Key: 7333564
• Report Number: 1821850-2017-00013
• Device Sequence Number: 11052805
• Product Code: DRM
• UDI-Device Identifier: 00860682000107
• UDI-Public: (01)00860682000107(11)160928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K851139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1