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

Model Number 1008

Device Problem Protective Measures Problem (3015)

Patient Problem Death (1802)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated by the distributor (trained and certified by the manufacturer) who confirmed the customer's initial complaint.They determined the malfunction of the device was isolated to the igor valve, (a pneumatic component driven by electronic signals).The electronic wire connector to the igor was re-positioned, secured and the device was re-tested to all final test procedures.The distributor confirmed the device passed all final testing and returned the device to the customer.

Event Description

It was reported that the device was being used on a patient to perform cpr.It was reported the device stopped compressions after 30 minutes of operation.Patient was not revived.It was the operator's opinion that the problem with the device did not contribute to the death of the patient.

• Brand Name: LIFE-STAT
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, LLC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer (Section G): MICHIGAN INSTRUMENTS, LLC; 4717 talon ct. se; grand rapids MI 49512
• Manufacturer Contact: chris blanker ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 7970136
• MDR Text Key: 123961198
• Report Number: 1821850-2018-00002
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 MO
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• 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
• Patient Weight: 70