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

Model Number P7500A001475

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 10/31/2023

Event Type  Injury  

Event Description

On 11/21/23, the customer reported 2 new pressure injuries had been observed in patients using progressa beds.There was no report of device malfunction.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

On 11/21/23, the customer reported 2 new pressure injuries had been observed in patients using progressa beds.There was no report of device malfunction.On 11/30/23, the hospital's bedsore referral nurse provided additional information on the reported injuries.It was noted that a patient was placed on the progressa bed with sn (b)(6).On 11/7/2023, and his/her pre-existent stage 1 pressure injury on the heel deteriorated in stage 3.The patient also developed an occipital pressure injury; however, stage was not specified.The new pressure injury and the deterioration in the pre-existing one were observed on 11/25/23.The nurse noted the patient developed the reported pressure injuries before device training was provided, and she will work with a trained nurse to check mattress mode and comfort.The bed's pressures were checked and found in the expected ranges.Specific details of the event including medical/surgical intervention provided, the patient¿s medical history, accessory devices utilized, and the facility's positioning protocols were not provided.The progressa bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility, pressure ulcers, or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.Additionally, the instructions for use (ifu) states 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.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the progressa 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.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.In this event, the deterioration of the patient's stage 3 heel pressure injury meets the definition of a serious injury.There was no report of device malfunction and the bed's pressures were noted to be in the expected ranges.Additionally, the device ifu provides complete instructions on the use of the bed.Based on the information provided, there is no indication that a malfunction of the progressa bed caused or contributed to the reported injury, however, use error cannot be ruled out as the reported injuries occurred before device training was provided.Hillrom representatives continue to work with the customer to optimize the staff¿s understanding of the bed, as well its functions.If use error were to recur, it would be unlikely to result in serious injury as preventative measures and therapy instructions are outlined in the ifu.If additional relevant information is received, the complaint will be reassessed.

• 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18324427
• MDR Text Key: 330481543
• Report Number: 1824206-2023-01390
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/14/2023

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: P7500A001475
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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