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

Model Number 1008

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not being returned to the manufacturer for evaluation.No other information is available.

Event Description

After 10minutes, life stat stopped working and chest compressions were immediately started (manually).

• 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: 9078616
• MDR Text Key: 193366678
• Report Number: 1821850-2019-00002
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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 Weight: 91