MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, FLOTATION THERAPY, POWERED

Model Number P7500A001079

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Hillrom has also been working with the customer to identify the 11 beds impacted, so that an inspection can be carried out to determine malfunction.The customer has not been able to provide specific details in relation to which serial number each patient is related to.At the time of this evaluation, the customer could not confirm the specific device associated with this event, as the investigation is still ongoing to determine the appropriate device involved and its functionality.If any additional relevant information is received the event will be categorized accordingly.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.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.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.Additionally, the device instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice and the device therapy modes should be used in conjunction with good assessment and protocol.A stage 4 pressure almost always requires medical or surgical intervention to preclude permanent damage to a body structure and it is noted that this patient required surgery, therefore, meeting the definition of a serious injury.Additionally, at the time of this evaluation, malfunction of the device could not be ruled out and the customer could not confirm the use of this device, as the investigation is still ongoing to determine the functionality of the device and the appropriate device involved.Therefore hillrom considers this event as reportable.

Event Description

The customer reported experiencing an increase in pressure injuries with the use of the hillrom progressa bed.The customer reported that 11 patients developed nosocomial pressure injuries, which will be evaluated individually.This evaluation is for patient-7 who was reported to have a stage 4 heel pressure injury.It was also reported that this patient had surgery.This report was filed in our complaint handling system as complaint #(b)(4).

Event Description

The customer contributes the patient's (patient 7) stage 4 heel pressure injury to the use of the progressa bed.The customer reported the 51-year-old patient was an intensive care patient with two vital failures, sedated, curarized (paralyzed), and ventilated.The customer also reported that surgical intervention was provided for the pressure injury.Further details of the patient¿s current or past medical history or medical interventions were not provided.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer contributes the patient's (patient 7) stage 4 heel pressure injury to the use of the progressa bed.The customer reported the 51-year-old patient was an intensive care patient with two vital failures, sedated, curarized (paralyzed), and ventilated.The customer also reported that surgical intervention was provided for the pressure injury.Further details of the patient¿s current or past medical history or medical interventions were not provided.The customer reported the facility positioning protocols were according to current recommendations, and is governed by the consensus conference on the prevention of the risk of bedsores, i.E.Mobilization every two hours, however, no documentation was provided to confirm that this occurred.As the customer cannot specify which patient was on which bed all 11 beds and surfaces were thoroughly inspected by the hrc technician and it was confirmed that the beds are functioning correctly and in accordance with the technical manual: no errors.Airflow works with 30kg on the bed.All values are within the ranges of the technical documentation.The pressures measured were in compliance with the expectations.No malfunction, the bed was performing within specifications.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.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of 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.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.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.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.No malfunction was identified during the inspection of the bed and determined to function as designed.A stage 4 pressure injury involves full-thickness skin and tissue loss with exposed fascia, muscle, tendon, ligament, cartilage, or bone.Treatment for a stage 4 pressure injury typically involves surgical intervention to preclude permanent impairment of the body structure.Therefore this event is a reportable serious injury.

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12217444
• MDR Text Key: 263142006
• Report Number: 1824206-2021-00383
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P7500A001079
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR