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

Model Number P7500A000536

Device Problem Unclear Information (4052)

Patient Problems Pressure Sores (2326); Insufficient Information (4580)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported a significant increase in pressure sores and redness during the pandemic emergency while using progressa beds.Per the customer, there are currently 10 progressa pulmonary pro875 beds in this hospital.Specific details of the pressure sores including the number of occurrences, stage and location, if the pressure sores were preexisting or newly acquired, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols have been requested, but not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 1 of 10.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.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.Attempts to obtain additional details to determine severity of the event including injury, medical intervention provided (if any), and patient outcome have been unsuccessful.Additionally, the device is pending inspection.If additional relevant information is received, the complaint will be reassessed and the injury will be categorized accordingly.Based on the limited details available and the potential for serious injury, hillrom considers this complaint reportable.No further information is available on the device at this time, however any new additional and relevant information that is identified following completion of the investigation will be provided in a final report.

Event Description

The customer reported a significant increase in pressure sores and redness during the pandemic emergency while using progressa beds.Per the customer, there are currently 10 progressa pulmonary pro875 beds in this hospital.Specific details of the pressure sores including the number of occurrences, stage and location, if the pressure sores were preexisting or newly acquired, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols have been requested, but not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 1 of 10.The beds are located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported a significant increase in pressure sores and redness during the pandemic emergency while using progressa beds.Per the customer, there are currently 10 progressa pulmonary pro875 beds in this hospital.Specific details of the pressure sores including the number of occurrences, stage and location, if the pressure sores were preexisting or newly acquired, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols have been requested, but not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 1 of 10.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.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.Attempts to obtain additional details to determine severity of the event including injury, medical intervention provided (if any), and patient outcome have been unsuccessful.Additionally, the device is pending inspection.If additional relevant information is received, the complaint will be reassessed and the injury will be categorized accordingly.Based on the limited details available and the potential for serious injury, hillrom considers this complaint reportable.18may2022, clinical evaluation update: multiple attempts were made to obtain specific details about the reported increase in pressure sores; however, no additional information could be obtained from the customer.Inspection of the bed by a hillrom technician found the bed and its components to be working as designed.The customer did not provide the necessary information to determine the severity of the injuries.Based on the limited details provided, there is no indication that the reported pressure sores were serious injuries.If any additional relevant information is received the event will be categorized accordingly.This event is not reportable.Based on this information, no further action is required.

Event Description

The customer reported a significant increase in pressure sores and redness during the pandemic emergency while using progressa beds.Per the customer, there are currently 10 progressa pulmonary pro875 beds in this hospital.Specific details of the pressure sores including the number of occurrences, stage and location, if the pressure sores were preexisting or newly acquired, medical intervention, past medical history, accessory devices utilized, and facilities positioning protocols have been requested, but not provided.Additionally, the customer did not associate a patient with a specific bed serial number.This evaluation addresses complaint 1 of 10.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: 13715243
• MDR Text Key: 296955198
• Report Number: 1824206-2022-00134
• 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,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A000536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• 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