MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA BED SYSTEM; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number LPROGRESSA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Patients developed stage 3 up to stage 4 pressure ulcers on the occipital area of the scalp.Medical intervention for the pressure ulcers has included wound vac therapy.Some wounds have required surgery to close the wounds.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.Hill-rom has investigated the progressa bed systems noted in these complaints.It was noted these beds had not received a field safety corrective action that was released in 2016 to correct unexpected software issues that affected the performance of the therapy mattress.The software issue was related to how the air system utilizes data from the bed scale to set bladder pressure points.When errors occur, the software does not convert the patient weight to the air system correctly.In some cases the pressure setting of the bladders may be higher or lower than the optimal pressure range.In some cases, patients that are already high risk may become more susceptible to pressure ulcers.This issue does not affect the accuracy or calibration of the progressa scale weighing function.If the scale provides a weight reading to the user, it will be accurate.Symptoms may not be observed all of the time, but if the malfunction manifests there will be no weight reading given by the bed or an error will occur.The customer had reported to us they were also having trouble with the scales on these beds.Hill-rom is continuing to investigate the performance of these progressa bed systems.As an initial correction, a hill-rom representative has upgraded the software of the affected progressa beds per the requirements of the field safety corrective action.

Event Description

Hill-rom has become aware of incidences where the customer has alleged patients have developed pressure ulcers on the occipital area of the scalp while using hill-rom's progressa bed system.(b)(4).

• Brand Name: PROGRESSA BED SYSTEM
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7169296
• MDR Text Key: 96581606
• Report Number: 1824206-2018-00014
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: LPROGRESSA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other