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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESOURCE OPTIMIZATION & INNOVATION, L.L.C. REGARD DEFIBRILLATOR PAD ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

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RESOURCE OPTIMIZATION & INNOVATION, L.L.C. REGARD DEFIBRILLATOR PAD ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Hyperglycemia (1905); Ulceration (2116); Impaired Healing (2378); Skin Tears (2516); Test Result (2695)
Event Date 06/29/2018
Event Type  malfunction  
Event Description
Skin alteration noted when patient bathed after coming out of the operating room (or) after surgery. Skin tear to left scapula in a square pattern. Per registered nurse, recognition of skin integrity impairment noted upon patient's transfer from the or. Per wound management note: "patient has an elevated creatinine, anemia, and hyperglycemia which can contribute to poor tissue perfusion and delayed healing, giving the patient a risk for skin breakdown. " since the conversion to the "regard" defibrillator pad in question, a sudden increase in skin tears have been noted. All cases reviewed, education completed by company representative to cardiovascular operating room team members and appropriate removal technique reviewed. I would also like to note, this pad is utilized along with a warming blanket, known as the blanketrol, to maintain patient temperature. Discussions with company rep have arose regarding the possibility of increased tackiness to the pad in production, as well as an increase in tackiness due to the blanketrol heat pad being used. Both theories are being reviewed. Regard defibrillator pad. Device is not available for return.
 
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Brand NameREGARD DEFIBRILLATOR PAD
Type of DeviceELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
Manufacturer (Section D)
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
3000 e sawyer rd
republic MO 65738
MDR Report Key8018517
MDR Text Key125488966
Report Number8018517
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2018
Event Location Hospital
Date Report to Manufacturer10/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/30/2018 Patient Sequence Number: 1
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