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

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.

• Brand Name: REGARD DEFIBRILLATOR PAD
• Type of Device: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): RESOURCE OPTIMIZATION & INNOVATION, L.L.C.; 3000 e sawyer rd; republic MO 65738
• MDR Report Key: 8018517
• MDR Text Key: 125488966
• Report Number: 8018517
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 10/30/2018
• 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 FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19710 DA