MAUDE Adverse Event Report: HILL-ROM MEXICO ACCUMAX VPC FOR VC W/HDLS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number PAF0052101XX-1

Device Problems Insufficient Information (3190); Unclear Information (4052)

Patient Problems Pressure Sores (2326); Insufficient Information (4580)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported after upgrading all their medical-surgical mattresses to accumax in 2020, they experienced a high rate of pressure ulcers.The customer could not associate a patient with a specific bed/serial number.At the time of this initial report, details of the severity of the pressure injuries or medical intervention, if any, were not 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 500 lb.(227 kg.).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.Multiple attempts to obtain additional details to determine severity of the event including injury, medical intervention provided, and patient outcome were unsuccessful.Additionally, the customer could not associate a patient with a specific bed/serial number.If additional relevant information is received, the complaint will be reassessed, and the injury will be categorized accordingly.Based on the limited details available and the potential for serious injury, hillrom considers this complaint reportable.

Event Description

The customer reported after upgrading all their medical-surgical mattresses to accumax in 2020, they experienced a high rate of pressure ulcers.The customer could not associate a patient with a specific bed/serial number.At the time of this initial report, details of the severity of the pressure injuries or medical intervention, if any, were not provided.Hillrom is reporting this bed and providing information on its location as a potentially malfunctioning bed until further information becomes available and the bed has been fully inspected by a hrc technician.Once further clinical information becomes available, hillrom will file a supplemental report this report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported after upgrading all their medical-surgical mattresses to accumax in 2020, they experienced a high rate of pressure ulcers.The customer could not associate a patient with a specific bed/serial number.At the time of this initial report, details of the severity of the pressure injuries or medical intervention, if any, were not provided.Multiple attempts to obtain additional details to determine severity of the event including injury, medical intervention provided, and patient outcome were unsuccessful.Additionally, the customer could not associate a patient with a specific bed/serial number.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 500 lb.(227 kg.).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.Additional customer information received: follow-up from the customer confirmed most of the pressure injuries involved were between stages 1 and 2 and involved later stages in only a small number of cases.The customer states a few of the pressure injuries were pre-existing and developed during the patient¿s icu stay (prior to being transferred to the ward); however, most cases developed pressure injuries after being transferred to the ward.Medical intervention for the pressure injuries included wound care, hydrogel dressings, antibiotics, and surgical consultation (if needed).The patients were noted to have been on the beds between three days to three weeks.Additional devices being used to help manage the pressure injuries included gel pads for patient positioning and approximately 1-2 sheets (35% cotton, 65% polyester) under each patient.The customer repositioning protocol is noted as every two hours.Information regarding device audible/visual error message and specific pressure mode of the mattress was asked, however the customer did not provide.Additional customer information received 7/26/2022.The customer only noted stage 1 and 2 pus (which are not serious) but noted, and later stages in some cases.The customer declined to provide additional information on the injuries, number of patient, and is not having the beds inspected.The customer did request training for staff on how to use the beds/mattresses.If additional relevant information is received, the complaint will be reassessed, and the injury will be categorized accordingly.Based on the limited details available and the potential for serious injury, hillrom considers this complaint reportable.

Event Description

The customer reported after upgrading all their medical-surgical mattresses to accumax in 2020, they experienced a high rate of pressure ulcers.The customer could not associate a patient with a specific bed/serial number.Details of the severity of the pressure injuries or medical intervention, if any, were not provided.The customer only noted stage 1 and 2 pus (which are not serious) but noted, and later stages in some cases.The customer declined to provide additional information on the injuries, number of patient, and is not having the beds inspected.The customer did request training for staff on how to use the beds/mattresses.This report was filed in our complaint handling system as complaint#: (b)(4).

• Brand Name: ACCUMAX VPC FOR VC W/HDLS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14317954
• MDR Text Key: 291306083
• Report Number: 3006697241-2022-00025
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Followup
• Report Date: 08/08/2022

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?: Yes
• Device Model Number: PAF0052101XX-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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