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

Model Number P7500A000168

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that there was an issue with the top chamber of the progressa bed and the patient has a wound.Follow-up with the customer found that the patient has a stage 4 pressure injury which is currently being treated with a wound vac.During the call, the customer also stated the patient was recently hospitalized for 15 days but declined to provide any details of the hospitalization and any further details of the reported event.It could not be determined if the patient's wound was preexisting prior to this event.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 progressa bed and its graphical caregiver interface functions to provide an audible and visual notification of a potentially hazardous condition and prompt the user to take appropriate action to correct the situation or remove the patient from the bed.Upon the arrival of a hillrom technician at the patient's home for an inspection of the bed, the customer stated that the outlet that the bed was plugged into was faulty.The inspection of the bed found the bed to be working properly when plugged into a different outlet.A stage 4 pressure injury extends below the subcutaneous fat into muscle, tendons, and ligaments.In more severe cases, they can extend as far down as the cartilage or bone.Treatment for a stage 4 pressure injury typically involves surgical intervention to preclude permanent impairment of the body structure.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Although the bed was found to be working as designed, the reported stage 4 pressure injury is considered a serious injury therefore hillrom considered this injury reportable.

Event Description

It was reported that there was an issue with the top chamber of the progressa bed and the patient has a wound.Follow-up with the customer found that the patient has a stage 4 pressure injury which is currently being treated with a wound vac.During the call, the customer also stated the patient was recently hospitalized for 15 days but declined to provide any details of the hospitalization and any further details of the reported event.It could not be determined if the patient's wound was preexisting prior to this event.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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 14342176
• MDR Text Key: 291373131
• Report Number: 1824206-2022-00237
• 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
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7500A000168
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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