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

Model Number P7500A001494

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported a patient developed a potential deep tissue injury (pdti) to the abdomen coincident with use of the progressa bed.There was no allegation of a device malfunction.The patient in this event was a 47-year-old male who weighed 123.5 kg and had a medical history of type 2 diabetes mellitus and high body mass index (bmi).The patient was admitted on (b)(6) 2022 post-operatively (type of surgery not reported), intubated/ventilated and requiring inotropic support (noradrenaline).On (b)(6) 2022, the patient experienced increased respiratory failure and required prone positioning on two occasions for a duration of 21 and 24 hours.On (b)(6) 2022, a pdti to the abdomen was noted.No medical intervention was required, and the pdti was being monitored while awaiting tissue viability nurse (tvn) support.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, support from the tvn was pending and outcome of the pdti assessment was unknown.Additionally, an inspection of the device is pending.A serious injury or malfunction cannot be excluded at this time.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.No further information is available on the repair of the bed at this time, as the bed has not been made available for an inspection to occur.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported a patient developed a potential deep tissue injury (pdti) to the abdomen coincident with use of the progressa bed.There was no allegation of a device malfunction.The patient in this event was a 47-year-old male who weighed 123.5 kg and had a medical history of type 2 diabetes mellitus and high body mass index (bmi).The patient was admitted on (b)(6) 2022 post-operatively (type of surgery not reported), intubated/ventilated and requiring inotropic support (noradrenaline).On (b)(6) 2022, the patient experienced increased respiratory failure and required prone positioning on two occasions for a duration of 21 and 24 hours.On (b)(6) 2022, a pdti to the abdomen was noted.No medical intervention was required, and the pdti was being monitored while awaiting tissue viability nurse (tvn) support.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) to the abdomen coincident with use of the progressa bed.There was no allegation of a device malfunction.The patient in this event was a 47-year-old male who weighed 123.5 kg and had a medical history of type 2 diabetes mellitus and high body mass index (bmi).The patient was admitted on (b)(6) 2022 post-operatively (type of surgery not reported), intubated/ventilated and requiring inotropic support (noradrenaline).On (b)(6) 2022, the patient experienced increased respiratory failure and required prone positioning on two occasions for a duration of 21 and 24 hours.On (b)(6) 2022, a pdti to the abdomen was noted.No medical intervention was required, and the pdti was being monitored while awaiting tissue viability nurse (tvn) support.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, support from the tvn was pending and outcome of the pdti assessment was unknown.Additionally, an inspection of the device is pending.A serious injury or malfunction cannot be excluded at this time.20jan2023, clinical evaluation update: the following additional information was received from the customer.The patient was admitted to the unit following an incision and drainage of a neck abscess and was on high oxygen concentration.A purpose t pressure ulcer risk assessment was performed, and no pressure ulcer was noted.The patient was being turned every 4 hours as able; however, this turning frequency was not followed when the patient was in prone position.Hospital provided laundry was the only material being used on the progressa bed.No medical treatment was required for the pdti.The customer was unsure if the progressa bed contributed to the pdti, and no specific device malfunction was alleged.Additionally, due to the report of non-compliance with turning protocols while prone, a use error cannot be excluded as causing or contributing to the pdti.On (b)(6) 2022, the patient died.Per the customer, the patient¿s death was unrelated to the pdti.Attempts by hillrom to gain access to the progressa bed to perform an inspection have been unsuccessful and a device malfunction cannot be excluded at this time.Additionally, the outcome of the pdti was unknown and is therefore considered a serious injury for the reasons stated above.It is noted the patient experienced increased respiratory failure on (b)(6) 2022.Per the customer, the patient¿s death on (b)(6) 2022 was unrelated to the pdti.It is unlikely the progressa bed caused or contributed to the patient¿s death.Should additional information become available, the complaint will be reassessed.Hillrom has been to the account three times attempting to inspect the bed.During each attempt the bed has been unavailable for inspection due to continuing to be in use.Based on this information, no further action is required.

Event Description

The customer reported a patient developed a potential deep tissue injury (pdti) to the abdomen coincident with use of the progressa bed.There was no allegation of a device malfunction.The patient in this event was a 47-year-old male who weighed 123.5 kg and had a medical history of type 2 diabetes mellitus and high body mass index (bmi).The patient was admitted on (b)(6) 2022 post-operatively (type of surgery not reported), intubated/ventilated and requiring inotropic support (noradrenaline).On (b)(6) 2022, the patient experienced increased respiratory failure and required prone positioning on two occasions for a duration of 21 and 24 hours.On (b)(6) 2022, a pdti to the abdomen was noted.No medical intervention was required, and the pdti was being monitored while awaiting tissue viability nurse (tvn) support.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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15951711
• MDR Text Key: 305187065
• Report Number: 1824206-2022-00525
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2020
• 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
• Patient Age: 47 YR
• Patient Sex: Male