MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC BED; BED, FLOTATION THERAPY, POWERED

Model Number P1830ACAP

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

It was alleged that the mattress on the totalcare bariatric bed was not supportive, and the patient developed pressure wounds.No further information was provided.The following information was obtained from the patient.The patient acquired the totalcare bed approximately 15 years ago.Last (b)(6) 2022, the air system stopped working and in approximately (b)(6) 2022 the patient developed 3 pressure injuries on her "backside" and in the "fecal area." the patient stated the pressure injuries were initially a stage 3 and have improved to stage 2.A home health nurse visits 3 times a week and performs dressing changes to the pressure injuries.The patient can get up to a chair and walk a few steps with assistance of a walker.The patient's medical history includes bilateral separated rotator cuff, copd (non-smoker), diabetes mellitus, obesity, lumbar stenosis, "partial paralysis of leg muscles due to not being mobile,¿ and reportedly needs bilateral knee replacements.The patient stated the bed was alarming at the time of the event in 2022 and has been alarming ever since (specific alarm not reported).Additionally, the head of the bed intermittently will not go down.Baxter inspected the totalcare bed, but the patient cannot afford the repairs.No additional information was provided.The totalcare bariatric bed and totalcare bariatric plus therapy system are intended to provide a patient support ideally suited for use in healthcare environments.The totalcare bariatric bed and totalcare bariatric plus therapy system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The baxter service technician performed an inspection of bed serial number (b)(6) and observed the bed to have a non-functioning air system, non-functioning graphical caregiver interface (gci) left head, and the right head gci was duct taped to the inner right siderail with limited function.The technician entered an air reset code but there was no response.The patient stated the air system has not functioned for over six months and has been alarming but she has been sleeping on it nightly.The bed articulations were working slowly and squealing.The bed cosmetics were non-compliant with a properly functioning bed.The bed was in a very small room with no space around it and the condition of the home prohibited further troubleshooting.No repairs were made at the time of inspection due to patient financial constraints.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the totalcare bed.Pressure injuries can develop within 2-6 hours when capillaries supplying the skin and subcutaneous tissues are compressed, causing an obstruction in blood flow, which ultimately leads to tissue necrosis.Position changes are key to pressure injury 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.Prevention of pressure injuries involves a multidisciplinary approach including rapid identification of at-risk individuals such as those with diabetes, incontinence, impaired mobility, peripheral vascular disease, etc., and exercising a vigilant prevention protocol consisting of skincare, nutritional assessment reducing mechanical load, and utilizing support surfaces.In this event, the patient developed a stage 3 pressure injury that required medical intervention and reportedly improved to stage 2.A stage 2 pressure injury is categorized as partial thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed, without slough.It may also present as an intact or open/ruptured serum-filled or serosanguinous filled blister.Such injuries can heal very rapidly therefore treatment is focused on nutrition to support wound healing protected/covered and clean.A stage 3 pressure injury is categorized as full thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.A stage 3 pressure injury often requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore meets the definition of a serious injury.The ultimate cause of the reported event is undetermined, but likely multifactorial due to the patient¿s medical history, immobility, and prolonged use of the totalcare bed with a known non-functioning air system.If the reported problems of deflated mattress/non-functional air system and non-functional gci were to recur, it would be unlikely to cause or contribute to a death or serious injury, unless the patient continued to use (use error) the bed in its non-functioning state.Additionally, the bed alarmed and provided appropriate notification to the user/patient of a condition that required attention and the user/patient continued use of the bed for an extended length of time before contacting baxter.

Event Description

It was alleged that the mattress on the totalcare bariatric bed was not supportive, and the patient developed pressure wounds.No further information was provided.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TOTALCARE BARIATRIC BED
• 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: 17595940
• MDR Text Key: 321647619
• Report Number: 1824206-2023-00939
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P1830ACAP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1