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

Model Number 1008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that the device runs for 10 minutes and then the compressions start to stop or bind up.It was reported that the problem occurred when in use on a patient, and manual compressions were resumed.Paitent was not revived.It is the operator's opinion that the problem with the device did not contribute to the death of the patient.

Manufacturer Narrative

Upon receipt, customer complaint of device functioning initially and then stopping was confirmed.The device has been in service for 10 years but has not been back for factory service.Recommended replacement of the membrane switch, turbin valave assembly and the timing regulator, all of which would have been addressed had factory maintenance been performed at the recomended 5 year intervals.Customer declined the repairs and indicated they would take it out of service.

• 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: 18971432
• MDR Text Key: 338765916
• Report Number: 1821850-2024-00001
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/21/2024

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: Health Professional
• Device Model Number: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG