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

Model Number 1008

Device Problem Device Inoperable (1663)

Patient Problem Heart Failure (2206)

Event Date 07/30/2017

Event Type  malfunction  

Manufacturer Narrative

This unit was returned to the factory and was extensively evaluated.After many hours of testing the compalint could not be confirmed.Is was noted that this unit has never received recomended factory service and has been used beyond its' expected service life without this recommended maintenance.The unit will be serviced and updated and returned to the customer.

Event Description

The device was applied to a patient in cardiac arrest.It was reported that after 30 minutes of use compressions suddenly stopped.The unit was removed from the patient and manual cpr continued.The unit was able to be restarted.The patient was not revived.The user stated that the failure did not contribute to the death of the patient.

• Brand Name: LIFE-STAT
• 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: jim maatman ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 7333560
• MDR Text Key: 102340931
• Report Number: 1821850-2017-00011
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K073079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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: 58 YR
• Patient Weight: 51