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 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, customer complaint of ventilation volume not functioning was confirmed.Ventilation knob was found to be rotating around the ventilation needle stem.This was due to set screws being rounded off on the ventilation needle stem.Replaced set screws in ventilation knob.Tested and accepted to factory specifications and returned to customer.

Event Description

It was reported that the ventilation knob was non-functional.

• 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: 17435806
• MDR Text Key: 320161442
• Report Number: 1821850-2023-00001
• 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: 08/01/2023

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: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2012
• 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