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

Model Number P7500A001648

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

The customer reported the occurrence of a patient¿s 2-inch x 6-inch pressure injury, ¿suspected deep tissue damage¿ (unknown body location), associated with a progressa bed which occurred two days after the patient was hospitalized.The customer did not allege a device malfunction, and specific details of the event including, clarification if the patient¿s pressure injury was preexisting, the medical treatment provided for the injury, patient¿s medical history, accessory devices utilized, and the facility¿s positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed/serial number.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The customer reported the occurrence of a patient¿s 2-inch x 6-inch pressure injury, ¿suspected deep tissue damage¿ (unknown body location), associated with a progressa bed which occurred two days after the patient was hospitalized.The customer did not allege a device malfunction, and specific details of the event including, clarification if the patient¿s pressure injury was preexisting, the medical treatment provided for the injury, patient¿s medical history, accessory devices utilized, and the facility¿s positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed/serial number.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.Deep tissue pressure injuries (dtpi) are persistent non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.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, dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.For this event, there was no allegation of malfunction.Based on the limited information provided on the patient¿s ¿suspected deep tissue damage¿ a serious injury cannot be excluded at this time.It is noted that the customer did not associate the reported injury with a specific bed, therefore a device inspection is pending at this time as the investigation is ongoing.If any new relevant information is received the complaint will be addressed accordingly.

Manufacturer Narrative

The customer reported the occurrence of a patient¿s 2-inch x 6-inch pressure injury, ¿suspected deep tissue damage¿ (unknown body location), associated with a progressa bed which occurred two days after the patient was hospitalized.The customer did not allege a device malfunction, and specific details of the event including, clarification if the patient¿s pressure injury was preexisting, the medical treatment provided for the injury, patient¿s medical history, accessory devices utilized, and the facility¿s positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed/serial number.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.Deep tissue pressure injuries (dtpi) are persistent non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.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, dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.For this event, there was no allegation of malfunction.Based on the limited information provided on the patient¿s ¿suspected deep tissue damage¿ a serious injury cannot be excluded at this time.It is noted that the customer did not associate the reported injury with a specific bed, therefore a device inspection is pending at this time as the investigation is ongoing.If any new relevant information is received the complaint will be addressed accordingly.16october2023 update with receipt of inspection details.It was initially reported that a pressure injury 2-inch x 6-inch pressure injury, ¿suspected deep tissue damage¿ (unknown body location), associated with a progressa bed which occurred two days after the patient was hospitalized.The customer did not allege a device malfunction, and specific details of the event including, clarification if the patient¿s pressure injury was preexisting, the medical treatment provided for the injury, patient¿s medical history, accessory devices utilized, and the facility¿s positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed/serial number.An inspection of all the hillrom bed's associated with this reported event noted that all were found to be working as designed with no active errors/faults.Additionally, further investigation the bed's logfiles indicates that the beds were not used at the time of the event or the timeframe of the reported development of the pressure injuries.Therefore, it can be concluded that the reported serious injury of "suspected deep tissue damage" was not caused or contributed by the progressa bed.

Event Description

The customer reported the occurrence of a patient¿s 2-inch x 6-inch pressure injury, ¿suspected deep tissue damage¿ (unknown body location), associated with a progressa bed which occurred two days after the patient was hospitalized.The customer did not allege a device malfunction, and specific details of the event including, clarification if the patient¿s pressure injury was preexisting, the medical treatment provided for the injury, patient¿s medical history, accessory devices utilized, and the facility¿s positioning protocols were not provided.Additionally, the customer did not associate a patient with a specific bed/serial number.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: 17698014
• MDR Text Key: 322817546
• Report Number: 1824206-2023-01040
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2023
• 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