MAUDE Adverse Event Report: CHANGE HEALTHCARE ISRAEL LTD. MCKESSON CARDIOLOGY HEMO

Model Number MC 13.0 HF 3

Device Problems No Display/Image (1183); No Device Output (1435); Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 02/28/2017

Event Type  Death  

Manufacturer Narrative

An investigation is ongoing to determine the root cause of the ecg waveforms not displaying on the real time monitor.A follow-up report will be submitted to the fda upon conclusion of the investigation.

Event Description

Prior to commencing an emergency case on a patient exhibiting heart arrhythmia, the ecg waveforms on the mckesson cardiology hemo rtmonitor went blank.The user switched to using a defibrillator to monitor ecg waveforms for commencing and monitoring the procedure.During insertion of a temporary pacemaker, the patient expired.

Manufacturer Narrative

Change healthcare has identified an issue where, under certain conditions, the real time monitor (rtm) may not display physiological signals.This issue may occur when a user selects a patient from the patient list, and the associated patient records include an unusually high number of procedures.This issue may cause a blank or intermittent display on the rtm.Change healthcare has developed software updates to address the problem.Although the ecg waveforms were not displayed on the rtm during the emergency procedure, the patient's ecg waveforms were monitored using a defibrillator during the duration of the procedure.The customer indicated that the lack of the display of the ecg waveform was not the cause of the patient outcome.In addition, change healthcare will work with potentially affected customers to apply a software update to prevent the recurrence of the problem.Please note that the company names have changed since the initial mdr.Mckesson (b)(4) ltd.Is now change healthcare (b)(4) ltd.And mckesson technologies llc is now change healthcare technologies, llc.

Event Description

Prior to commencing an emergency case on a patient exhibiting heart arrhythmia, the ecg waveforms on the mckesson cardiology hemo rtmonitor went blank.The user switched to using a defibrillator to monitor ecg waveforms for commencing and monitoring the procedure.During insertion of a temporary pacemaker, the patient expired.

• Brand Name: MCKESSON CARDIOLOGY HEMO
• Type of Device: MCKESSON CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE ISRAEL LTD.; 26 harokmim st.; building a; holon, 58858 49; IS 5885849
• Manufacturer (Section G): CHANGE HEALTHCARE ISRAEL LTD; 26 harokmim st; building a; holon, 58858 49; IS 5885849
• Manufacturer Contact: paul sumner ; 5995 windward pkwy; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 6415275
• MDR Text Key: 70296678
• Report Number: 9616760-2017-00001
• Device Sequence Number: 1
• Product Code: DQK
• 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: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC 13.0 HF 3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• 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