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U.S. Department of Health and Human Services

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

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CHANGE HEALTHCARE ISRAEL LTD CHANGE HEALTHCARE CARDIOLOGY HEMO Back to Search Results
Model Number 14.1.1
Device Problems Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Patient Problem Death (1802)
Event Date 01/22/2020
Event Type  Death  
Manufacturer Narrative
The reporting facility stated that the device did not cause or contribute to the death of the patient. Initial investigation revealed the root cause of the reported malfunction is associated with the hardware components of the device. The hardware components were replaced, and then monitored by the reporting facility. The reporting facility confirmed the rt monitor is working as designed since the replacement. The hardware associated with the failure is under further investigation. Change healthcare will provide a follow up report to the agency once additional information is available.
 
Event Description
It was reported that during a procedure in the catheterization lab involving a patient in full cardiac arrest undergoing cpr, defibrillation, and artificial ventilation, that the rt monitor went blank multiple times and rebooted for several seconds and returned to full functionality. During the procedure and the reported rt monitor blanking out events, as indicated in the device instructions for use auxiliary devices were used to monitor the patient's vital signs. Subsequent to the procedure the patient expired.
 
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Brand NameCHANGE HEALTHCARE CARDIOLOGY HEMO
Type of DeviceCHANGE HEALTHCARE CARDIOLOGY HEMO
Manufacturer (Section D)
CHANGE HEALTHCARE ISRAEL LTD
26 harokmim st.
azrieli center building a
holon hamerkaz, israel 58858 49
IS 5885849
Manufacturer (Section G)
CHANGE HEALTHCARE ISRAEL LTD.
26 harokmim st.
azrieli center building a
holon hamerkaz, israel 58858 49
IS 5885849
Manufacturer Contact
chester mccoy
5995 windward parkway
alpharetta, ga 
3382088
MDR Report Key9731301
MDR Text Key180096750
Report Number9616760-2020-00002
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number14.1.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/20/2020 Patient Sequence Number: 1
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