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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO TOUCH/KINDRED PROTOUCH; EHR/MDDS
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PRO TOUCH/KINDRED PROTOUCH; EHR/MDDS Back to Search Results
Device Problem Human-Device Interface Problem (2949)
Patient Problems Low Blood Pressure/ Hypotension (1914); Complaint, Ill-Defined (2331); Cognitive Changes (2551)
Event Date 08/04/2014
Event Type  Injury  
Event Description
Data is often being deposited in the ehr in silence.No one becomes aware of new data on pts.Communication is stunted.There is a cognitive focus on the poorly usable ehrs associated with lapses in attention to the vital issues such as vital signs when the ehr saps attention of the user.In this case, the heart rate was 135 beats per minute for more than 12 hours without communication to doctor staff.Aides obtain the vital signs by machine that transmit directly to the ehr.Who knew.No one called the doctor, no one knew or processed the critical signs.The pt had delirium from hypotension requiring fluid resuscitation.The point of this is that these systems of devices distract and disrupt cognitive function of the user because of human factor deficiency in design, creating, in turn, fertile field for life threatening complications.
 
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Brand Name
PROTOUCH
Type of Device
EHR/MDDS
Manufacturer (Section D)
PRO TOUCH/KINDRED
louisville 40202
MDR Report Key4006278
MDR Text Key4712516
Report NumberMW5037720
Device Sequence Number1
Product Code LNX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 08/06/2014
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 Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/07/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age63 YR
Patient Weight66
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