MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC LIFE-STAT MODEL 1008; EXTERNAL CARDIAC COMPRESSOR

Model Number 1008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

During phone conversations with the logistics manager/users it was apparent that the reported problem was caused by a failed or improperly installed lip valve in the patient demand valve.This was determined based on the reported observations during and following the event.A replacement lip valve was sent and installed by the user.The device is now working properly.

Event Description

On an emergency call a patient was found in cardiac arrest and the unit was applied to provide cardiopulmonary resuscitation.It was reported that upon initiation of the resuscitation attempt proper chest compressions were performed but a lack of adequate chest rise was noticed.Ventilation volume was increased but there was no change in chest rise.At that point, the ventilation hose was removed and manual ventilation continued.The patient was not revived.Subsequent tests determined that the unit was not providing proper ventilation.The paramedic at the scene stated that the failure of the equipment did not contribute to the outcome.

• Brand Name: LIFE-STAT MODEL 1008
• 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: 4912242
• MDR Text Key: 22378781
• Report Number: 1821850-2015-00005
• 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 faci
• Reporter Occupation: Other
• Remedial Action: Repair
• Report Date: 07/14/2015

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: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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