MAUDE Adverse Event Report: MEDCON ISRAEL LTD. MCKESSON CARDIOLOGY HEMO; MCKESSON CARDIOLOGY HEMO, DQK

Model Number 13.1

Device Problems Decoupling (1145); Connection Problem (2900)

Patient Problem Sudden Cardiac Death (2510)

Event Date 09/27/2014

Event Type  Death  

Event Description

The reported facility alleged that the rt monitor displays in the control and procedure rooms momentarily went blank and then returned to a blue desktop screen during a stemi hemodynamic procedure.The displays automatically restored without waveforms or invasive pressure; other numeric valves were displayed, including heart rate and respiration.The ecg electrode were removed when the patient's initial, condition had been treated and stabilized.The patient's condition subsequently deteriorated, and the ecg electrode were replaced, and waveforms were restored on the displays.Throughout the procedure, auxiliary equipment, including a defibrillator and blood pressure units, were used to monitor the patient's condition.After being transferred to the ccu, where the patient's condition deteriorated; the patient subsequently expired.

Manufacturer Narrative

Based on the results of (b)(6) initial investigation with the reporting facility, the device did not cause or contribute to the death of the patient.Based on analysis of system log files, (b)(6) initial investigation determined that the rt monitor software application detected that no data was being received from the front-end monitoring component, the external control unit (ecu).When the rt monitor application detected that data was not being received from the ecu, it automatically attempted to restart the connection, as designed.As an immediate remedial action, the front-end monitoring components, including the ecu, cardiac unit (cu) and pb-1000, have been replaced.All connections have been checked and tested, and the system is functioning as intended.The root cause of the connection failure between the rt monitor and the ecu is currently unknown and is under investigation.Initial internal testing of the front-eng monitoring components that were replaced indicate that these hardware components are functioning as expected.

• Brand Name: MCKESSON CARDIOLOGY HEMO
• Type of Device: MCKESSON CARDIOLOGY HEMO, DQK
• Manufacturer (Section D): MEDCON ISRAEL LTD.; tel aviv ; IS
• Manufacturer (Section G): MEDCON MEDICAL IMAGING COMPANY
• Manufacturer Contact: paul sumner ; 5595 windward pkwy; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 4218531
• MDR Text Key: 20750256
• Report Number: 9616760-2014-00003
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 13.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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 Outcome(s): Death
• Patient Age: 48 YR
• Patient Weight: 102