MAUDE Adverse Event Report: HILL-ROM BATESVILLE MATTRESS, SAE, 48" (RENTAL); BED FLOTATION THERAPY POWERED

Model Number P6885

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 12/03/2021

Event Type  Injury  

Event Description

During device preventive maintenance (pm) check by a hillrom service technician it was noted that a synergy mattress cells were visually deflated, the bladder was not holding air and the patient who had previously been on the device developed skin breakdown.It is noted two bladders in the lower section of the mattress will need to be replaced.No report of malfunction or needed repair had been called in by the account for this event.The patient did not have any pre-existing wounds prior to being placed on the mattress and developed a deep tissue injury, full thickness stage three to his buttocks.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Follow up from the customer reports the patient was male and admitted for covid, however no further details on medical history, age or weight could be provided.The patient did not have any pre-existing wounds prior to being placed on the mattress and developed a deep tissue injury, full thickness stage three to his buttocks.Customer states they were unaware of the bed deflation and how long the patient had been on the device in this state.Medical intervention included a surgical debridement and the customer states this delayed the patient receiving physical therapy due to being unable to sit up in his chair.The patient has since been discharged to a long-term care facility.The hillrom synergy air elite (sae) low air loss therapy mattress is intended for patients in treating pressure ulcers.The product allows the end user options for individual skin safety programs when treating stage ii or stage iii pressure ulcers.The synergy air elite has a tri-cell over foam design that prevents bottoming out while lying on the surface.The device promotes healing with alternating pressure therapy by redistributing pressure points.The mattress system is comprised of a pressure regulated blower unit and a mattress replacement with 18 alternating cells which rest on a 2 inch foam base.All the cells are ventilated to provide a true low air loss therapy.The control unit supplies cycles of air pressure inflating and deflating the mattress cells continuously.Mattress instructions for use note the following safety tips: (1) with use of the unit, evaluate and monitor the patient.It may be necessary to change the patient¿s position from time to time.Failure to do so could cause patient injury.(2) keep the mattress away from sharp objects.Failure to do so could cause patient injury or equipment damage.Troubleshooting includes to examine the air cells for leaks.If a leak is found, contact hillrom technical support for assistance.The development of pressure ulcers is multifactorial and cannot be only attributed to the performance of the bed or its air system.Risk factors include protein-calorie malnutrition, microclimate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy.Position changes are key to pressure sore prevention and treatment.These changes need to be frequent, repositioning needs to avoid stress on the skin, and body positions need to minimize the risk of pressure on vulnerable areas.A stage three pressure ulcer involves full-thickness skin loss potentially extending into the subcutaneous tissue layer.Treatment can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.A stage iii pressure ulcer is considered a serious injury.If this malfunction were to re-occur the bed would visually be noted as deflated by the care team during patient checks and an inspection/ bed swap would occur.Proper procedures for prevention of this type of event are outlined per the ifu as noted above.The technician is waiting for parts on this repair but will be replacing two bladders in the lower section of the mattress.Hillrom is conservatively reporting this event due to the serious injury involved.

• Brand Name: MATTRESS, SAE, 48" (RENTAL)
• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13054545
• MDR Text Key: 284539054
• Report Number: 1824206-2021-00625
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2021

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 Model Number: P6885
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other