MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7500A001609

Device Problem Pressure Problem (3012)

Patient Problem Pressure Sores (2326)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

It was reported by a distributor that two patients at the customer facility developed a stage 3 pressure ulcer coincident with use of the progressa bed.This evaluation addresses patient 1 of 2.The male patient weighing (b)(6) kg was admitted to the hospital on (b)(6) 2022.The patient did not have a pre-existing pressure ulcer at the time of admission; however, the patient developed a stage 2 pressure ulcer of the heel, stage 2 sacral pressure ulcer, and stage 3 occipital pressure ulcer.Specific details of the pressure injuries including medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols were not provided.There was no allegation of a device malfunction.The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa bed is intended to provide a patient support to be used in health care environments.The progressa bed 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 progressa bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.Instructions for use state.The therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.Development of pressure ulcers 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 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.A stage 2 pressure injury may also present as an intact or open/ruptured serum-filled or serosanguinous filled blister.Stage 2 pressure injuries can heal very rapidly therefore treatment is focused on nutrition to support wound healing and keeping the area protected/covered and clean.Stage 1 and stage 2 pressure injuries are considered moderate injuries and do not meet the definition of a serious injury as they are not life threatening; do not result in permanent impairment of a body function or permanent damage to a body structure; and application of dermal creams or coverings does not constitute medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore is not considered reportable.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.An inspection of the facility¿s progressa beds was performed, and the beds were found to function as designed.Upon follow up with the customer, the nursing director was unable to confirm the reported event.However, due to the initial information received from the distributor, hillrom is cautiously reporting the event of stage 3 occipital pressure ulcer as a serious injury.Based on this information, no further action is required.

Event Description

T was reported by a distributor that two patients at the customer facility developed a stage 3 pressure ulcer coincident with use of the progressa bed.This evaluation addresses patient 1 of 2.Complaint number (b)(4) addresses patient 2 of 2.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 14190097
• MDR Text Key: 289906613
• Report Number: 1824206-2022-00220
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001609
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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