MAUDE Adverse Event Report: KAP MEDICAL ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	NA:MA65
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sores (2326)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The allegation that the ma65 caused/contributed to the end user developing pressure ulcers cannot be verified.Pressure ulcers are injuries to skin and underlying tissue resulting from pressure on the skin when resting in a position for an extended period and can occur regardless of the resting surface being used.Development of pressure ulcers is multifactorial.While the ma85 is designed to provide changes in the distribution of body pressure, the alleged malfunction of the device is only one of many contributing factors to the patient developing pressure ulcers.In addition to pressure, primary causes include friction and shear.Individual risk factors play a key role in increasing the end user¿s susceptibility to pressure sores, examples include but are not limited to end-user size, weight, immobility, lack of sensory perception, incontinence, medical conditions affecting blood flow, poor nutrition and poor hydration.The management, treatment, and prevention of pressure ulcers should be individualized and depends on the end user¿s medical history, risk factors and physical status.In all cases, care is pivotal in pressure ulcer prevention.Education, clinical judgment and action based planning based on vulnerability are fundamental factors in the prevention and treatment.It is very important for the end user to reposition themselves, or to be repositioned on a regular basis.It is the standard of care that the end user¿s condition should be monitored frequently and the care plan should be reviewed regularly by caregivers adjusting for changes in the end user¿s condition and environmental factors.Should additional information become available, a supplemental record will be filed.
Event or Problem Description
The end user relates that their ma65 alternating pressure mattress was sinking in the center.They tried to recalibrate the pump, but the center continues to sink.The caller states due to the center of the mattress sinking he developed a pressure sore which has progressed to the point his right ischium is visible.The caller stated in addition, he had a preexisting left side bed sore on his hip.His old and new bed sores are being treated by the wound clinic, and he is on bed rest.

• Brand Name: ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st; corona CA 92881
• MDR Report Key: 8073626
• Report Number: 1531186-2018-00009
• Device Sequence Number: 1895799
• Product Code: FNM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: NA:MA65
• Device Catalogue Number: MA65
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2018
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68