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

Model Number P7500A001694

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unclear Information (4052)

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

Event Date 05/16/2022

Event Type  Injury  

Event Description

The customer reported experiencing stage 3/stage 4 pressure injuries localized on the patient's knees, face, occiput, and sacrum with the use of the progressa bed.Specific details of the event including clarification if the associated patient¿s pressure injury was preexisting, the medical treatment provided for the pressure injury, patient¿s medical history, accessory devices utilized, and facilities positioning protocols were not provided.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported experiencing stage 3/stage 4 pressure injuries localized on the patient's knees, face, occiput, and sacrum with the use of the progressa bed.Specific details of the event including clarification if the associated patient¿s pressure injury was preexisting, the medical treatment provided for the pressure injury, patient¿s medical history, accessory devices utilized, and facilities 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.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.This report is in reference to a possible reportable malfunction and potential injury for the progressa bed with the serial #w138aw0304 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 grade (stage) 3 and/or grade 4 pressure injury almost always necessitates medical or surgical intervention to preclude permanent damage to a body structure and therefore meets the definition of a serious injury.Additionally, at the time of this evaluation, the functionality of the device could not be confirmed, as this investigation is still ongoing to determine specific details of the reported injury and identification of the device involved.If any additional relevant information is received the injury will be categorized accordingly.Therefore, this event is considered reportable.No further information is available on the evaluation and repair of the bed at this time.The investigation is ongoing, however any new additional and relevant information that is identified following completion of the investigation will be provided in a final report.

Manufacturer Narrative

The customer reported experiencing stage 3/stage 4 pressure injuries localized on the patient's knees, face, occiput, and sacrum with the use of the progressa bed.Specific details of the event including clarification if the associated patient¿s pressure injury was preexisting, the medical treatment provided for the pressure injury, patient¿s medical history, accessory devices utilized, and facilities positioning protocols were not provided.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 grade (stage) 3 and/or grade 4 pressure injury almost always necessitates medical or surgical intervention to preclude permanent damage to a body structure and therefore meets the definition of a serious injury.Additionally, at the time of this evaluation, the functionality of the device could not be confirmed, as this investigation is still ongoing to determine specific details of the reported injury and identification of the device involved.If any additional relevant information is received the injury will be categorized accordingly.Therefore, this event is considered reportable.Revision of clinical evaluation 17/11/2022 with the receipt of additional details.In this event, the patient was reported to have stage 3/stage 4 pressure injuries localized on the patient's knees, face, occiput, and sacrum with the use of the progressa bed.No additional details have been provided regarding the reported injury (preexisting, positioning protocols, medical intervention, etc.) were provided.Inspection of the device performed by a hillrom technician notes the bed was found to be functioning as designed.However, a grade (stage) 3 and/or grade 4 pressure injury almost always necessitates medical or surgical intervention to preclude permanent damage to a body structure and therefore meets the definition of a serious injury.Based on this information, no further action is required.

Event Description

The customer reported experiencing stage 3/stage 4 pressure injuries localized on the patient's knees, face, occiput, and sacrum with the use of the progressa bed.Specific details of the event including clarification if the associated patient¿s pressure injury was preexisting, the medical treatment provided for the pressure injury, patient¿s medical history, accessory devices utilized, and facilities positioning protocols were not provided.The bed was located at the account.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: 14687474
• MDR Text Key: 294782665
• Report Number: 1824206-2022-00285
• 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,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7500A001694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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