MAUDE Adverse Event Report: HILL-ROM MEXICO ACCUMAX CONV PREM CONT UNIT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number PCU2

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Pressure Sores (2326)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that an accumax mattress for home use was too hard and the patient experienced skin breakdown.Patient is a (b)(6)-year-old-male, weighing (b)(6) pounds and has a medical history of being handicap and a quadriplegic for approximately 13 years.Patient's mother states they noted a couple of weeks ago that her son had developed a pressure injury to his buttocks that was pink and bloody.She took her son to the hospital and the medical team diagnosed the patient with a stage three pressure injury to his right tailbone.The medical team provided supplies for home use to be applied to the wound and his mother states the wound is improving.The customer notes the mattress was purchased from hillrom approximately one month ago and they noticed the device as being too hard a couple of weeks after receiving.The device did not provide any audible/visual alerts.The customer confirmed after speaking to a hillrom representative the device was reset and now is functioning as designed with the bed being much softer than previously noted.The patient¿s mother additionally mentioned that they are pleased with the functionality of this device and all the help hillrom has provided.The accumax mattress is a therapeutic pressure redistribution system comprised of foam-filled air cylinders that aid in the prevention/treatment of pressure injuries in patients with up to moderate risk and/or stage i and ii pressure injuries when combined with recommended turning protocols.The accummax mattress can support a patient weight up to (b)(6).A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Development of pressure ulcers/injuries is multifactorial and cannot be only attributed to performance of the surface.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 3 pressure injury is defined as full thickness tissue loss.Subcutaneous fat may be visible, but the bone, tendon or muscle are not exposed.Treatment may include prescribed antibiotic therapy and at times removal of any dead tissue to help promote healing and prevent or treat infection.Although the device was noted to be functioning as designed; hillrom deems this a reportable event due to the serious injury involved.Based on this information, no further action is required.

Event Description

It was reported that an accumax mattress for home use was too hard and the patient experienced skin breakdown.Patient is a (b)(6)-year-old-male, weighing (b)(6) pounds and has a medical history of being handicap and a quadriplegic for approximately 13 years.Patient's mother states they noted a couple of weeks ago that her son had developed a pressure injury to his buttocks that was pink and bloody.She took her son to the hospital and the medical team diagnosed the patient with a stage three pressure injury to his right tailbone.The medical team provided supplies for home use to be applied to the wound and his mother states the wound is improving.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ACCUMAX CONV PREM CONT UNIT
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13562669
• MDR Text Key: 285854315
• Report Number: 3006697241-2022-00009
• Device Sequence Number: 1
• Product Code: IKY
• 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: 02/18/2022

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: PCU2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• 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
• Patient Outcome(s): Other