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

Model Number P7500A001494

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported a patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.No device malfunction was reported.The patient in this event was a 56-year-old female weighing 89 kg and measuring 1.63 m in height and reported to be ¿normally fit and well¿.The patient developed shortness of breath and was admitted to the unit on (b)(6) 2022 and was intubated/ventilated, receiving inotropic support and dialysis.A pressure ulcer risk assessment was performed on admission and the score was ¿amber¿.The patient was noted to have redness at the sacrum, which progressed to a pdti on (b)(6) 2022.No medical treatment was required.Hospital supplied sheets were used in addition to an incontinence pad, which was removed and changed to a bowel management system in situ on (b)(6) 2022.Hospital turning protocol was followed, however, the customer alleged the progressa bed contributed to the development of a pdti.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.The instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice.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 deep tissue pressure injury is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.Ulcers covered with slough or eschar are unstageable.Treatment can include frequent repositioning off the site of injury, good skin care, proper support surface selection, correcting any systemic issues or nutritional deficiencies and medical treatment from a wound care specialist.At times additional treatments can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.In some cases, a dti can resolve in a few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they can develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, there was no report of medical intervention required at the time of the initial report; however, a dti is considered a serious injury for the reasons stated above.Additionally, an inspection of the device is pending, and a device malfunction cannot be ruled out at this time.No further information is available at this time.The investigation is ongoing.Any additional, relevant information identified will be submitted in a final report.

Event Description

The customer reported a patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.No device malfunction was reported.The bed is located at the account.This report was filed in our complaint handling system as complaint (b)(4).

Event Description

The customer reported a patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.The bed is located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported a patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.The patient in this event was a 56-year-old female weighing 89 kg and measuring 1.63 m in height and reported to be ¿normally fit and well¿.The patient developed shortness of breath and was admitted to the unit on (b)(6) 2022 and was intubated/ventilated, receiving inotropic support and dialysis.A pressure ulcer risk assessment was performed on admission and the score was ¿amber¿.The patient was noted to have redness at the sacrum, which progressed to a pdti on (b)(6) 2022.No medical treatment was required.Hospital supplied sheets were used in addition to an incontinence pad, which was removed and changed to a bowel management system in situ on (b)(6) 2022.Hospital turning protocol was followed, however, the customer alleged the progressa bed contributed to the development of a pdti.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.The instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice.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 deep tissue pressure injury is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.Ulcers covered with slough or eschar are unstageable.Treatment can include frequent repositioning off the site of injury, good skin care, proper support surface selection, correcting any systemic issues or nutritional deficiencies and medical treatment from a wound care specialist.At times additional treatments can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.In some cases, a dti can resolve in a few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they can develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, there was no report of medical intervention required at the time of the initial report; however, a dti is considered a serious injury for the reasons stated above.Hillrom has made multiple (3+) attempts to inspect the bed; however, the bed was unavailable for inspection and no response has been received from the customer.A device malfunction cannot be ruled out at this time.Based on this information, no further action is required.H3 other text : 3 attempts for inspection.

• 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 16134582
• MDR Text Key: 307061199
• Report Number: 1824206-2023-00016
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7500A001494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2020
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 89 KG