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

Model Number 1008

Device Problem Device Stops Intermittently (1599)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

The device was applied to a patient in cardiac arrest.It was reported that after 20 minutes the device stopped for 5 seconds and then restarted.The device was removed from the patient and manual cpr was continued.The patient was not revived.It was reported by nurse ms.(b)(6) that the failure of the device did not contribute to the death of the patient.

Manufacturer Narrative

A thorough investigation was initiated and completed on this unit.Both mechanical and functional testing was done.The complaint was not confirmed when tested.When received the device showed significant wear but performed to specifications.It did need some calibration to return all adjustments to nominal which is expected due to the amount of use.

• Brand Name: LIFE-STAT
• Type of Device: EXTERNAL CARDIAC COMPRESSOR,
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, INC.; 4717 talon ct., s.e.; grand rapids MI 49512
• Manufacturer (Section G): MICHIGAN INSTRUMENTS, INC.; 4717 talon ct., s.e.; grand rapids MI 49512
• Manufacturer Contact: joe baldwin ; 4717 talon ct., s.e.; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 4202331
• MDR Text Key: 5147977
• Report Number: 1821850-2014-00005
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1008
• Device Catalogue Number: 16000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2013
• 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: 42 YR
• Patient Weight: 65