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

Model Number 1008

Device Problem Device Stops Intermittently (1599)

Patient Problem Heart Failure (2206)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

This failure was reported to us by the distributor.The user stated that this problem has happened several times.However, the device has not been returned for evaluation.We have, therefore, not been able to examine or test the unit to confirm the problem or determine the reason for the unit stopping.The device is currently in service.

Event Description

The device was applied to patients in cardiac arrest.It was reported that after thirty to forty minutes of use the the unit would suddenly stop.The device would suddenly stop quite often and would work again after a few minutes.The unit worked well before stopping.In each case the unit was removed from the patient and manual cardiopulmonary resuscitation was continued.The patients were not revived.The user stated that the failure did not contribute to the death of the patient.

Manufacturer Narrative

Evaluation of the unit determined the wire harness connector block had insufficient contact with the electronic leads on the solenoid.The wire harness was replaced, unit repaired, passed testing and returned to the customer.

• 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: 7333559
• MDR Text Key: 102340768
• Report Number: 1821850-2017-00008
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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: Nurse
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Date Manufacturer Received: 08/28/2017
• 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