MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, INC. LIFESTAT; CARDIOPULMONARY RESUSCITATOR

Model Number 1008

Device Problem Device Inoperable (1663)

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

Event Date 01/02/2014

Event Type  malfunction  

Event Description

Device was being used to perform cardiopulmonary resistation on a patient in cardiac arrest.It was reported that after 15 minutes when the control panel of the device failed to function.The device was removed from the patient and manual cpr continued.The patient was not revived.Attending nurse stated that the failure of the device did not contribute to the failure to revive the patient.

Manufacturer Narrative

A thorough investigation was initiated and completed on this unit.The complaint was confirmed but the unit (circuit board) has been modified by the user.The root cause of the problem could not be determined because the modifications damaged the circuit board of the control panel.This left the device in a condition where it would only partially function, making it difficult to evaluate the initial problem with the device.

• Brand Name: LIFESTAT
• Type of Device: CARDIOPULMONARY RESUSCITATOR
• 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: joe baldwin ; 4717 talon ct. se; grand rapids, MI 49512 ; 6165549696
• MDR Report Key: 3595072
• MDR Text Key: 4066003
• Report Number: 1821850-2014-00001
• 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,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2014

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: Nurse
• Device Model Number: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2010
• 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: 63 YR
• Patient Weight: 70