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

Model Number 1008

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Device was being used to perform cardiopulmonary resusitation on a patient in cardiac arrest.It was reported that after 10 minutes the device stopped and then started working again.The device was removed from the patient and manual cpr continued.The patient was not revived.The 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 could not be confirmed.The device performed to specifications when received.The only repair done to the unit was to apply a new label.

• Brand Name: LIFESTAT
• Type of Device: CARDIOPULMONARY RESUSCITATOR
• 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: 4202345
• MDR Text Key: 5041457
• Report Number: 1821850-2014-00006
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/26/2014

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: Other
• Device Model Number: 1008
• Device Catalogue Number: 16000Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/02/2014
• 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: 55 YR
• Patient Weight: 70