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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECARDIO ECARDIO VERITE
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ECARDIO ECARDIO VERITE Back to Search Results
Device Problems Computer Operating System Problem (2898); Device Sensing Problem (2917)
Patient Problems Syncope (1610); Death (1802); Fall (1848); Bone Fracture(s) (1870)
Event Date 04/24/2015
Event Type  Death  
Event Description
My father-in-law had an ecardio event monitor on when he fell on (b)(6) sometime around 1:15 in the morning.The medical device failed to monitor and record the low heart rate in the 27 bpm range until several hours later.We were told that the device would monitor bpm and both the doctor and patient would be alerted to the problem if the bpm was in an unsafe range.This did not happen and both the emergency room and the paramedics recorded a heart rate in the 26-35 bpm range.A letter from his cardiologist, dr.Alton, noted that no bradycardic episodes were recorded until 3:15 on (b)(6) 2015.The letter also states that he had syncopal episode at home 2 hours before this.We feel that the low bpm contributed to his broken femur and damage to his heart.We have been informed that this event has been reported to ecardio and is being investigated by a supervisor.He had a pacemaker inserted on (b)(6) /2015.The next day, (b)(6) 2015 he had surgery for his broken femur.The surgery for his femur was not successful and they did the surgery again on (b)(6) 2015.On (b)(6) 2015 he died of complications from the injury.
 
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Brand Name
ECARDIO VERITE
Type of Device
ECARDIO VERITE
Manufacturer (Section D)
ECARDIO
MDR Report Key4916210
MDR Text Key6011043
Report NumberMW5044157
Device Sequence Number1
Product Code DSI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2015
Patient Sequence Number1
Treatment
A LOT OF DIFFERENT MEDICATIONS; BLOOD BUILDER; METAMUCIL
Patient Outcome(s) Death; Hospitalization; Life Threatening; Other;
Patient Age87 YR
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