MAUDE Adverse Event Report: HILL-ROM BATESVILLE STAGE IV-3 23-SM3000-ARP; BED FLOTATION THERAPY POWERED

Model Number 23-SM3000-ARP

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found no malfunction with the mattress.During a follow-up call with the customer, the customer stated that the facility felt the blower malfunctioned, the light on the blower was flashing, and the nurse failed to respond appropriately to resolve the issue.No further information regarding the patient's medical intervention, medical history, or the event was provided by the customer.The stage iv mattress is a microprocessor-controlled therapeutic mattress system that provides three-zone alternating pressure and low air loss therapies for the treatment and/or prevention of pressure wounds.The bed provides notification byway or an audio-visual indicator when the air mattress does not reach the required pressure within 20 minutes.A stage iv pressure injury often requires medical or surgical intervention to preclude permanent impairment and therefore meets the definition of serious injury.However, the bed worked as designed by providing appropriate messaging to the user as acknowledged by the customer's recognition of the pump's flashing indicator.The reported injury can be contributed to the failure of the user to respond appropriately to resolve the issue.Thus this event is reportable.The stage iv systems are microprocessor controlled alternating pressure relief and low air loss therapeutic mattress systems.The needs of individual patients can be optimized by combining these therapies or operating them independently from each other.The alternating pressure feature of the stage iv systems provides pressure relief by deflating and inflating every other air cell on a timed interval.It is widely recognized that constant pressure to a bony prominence is a leading cause of skin breakdown.The stage iv systems provide continuous movement of air cells that alleviates constant pressure and enhances circulation.The deflated air cells provide pressure relief, while the inflated air cells support the patient¿s weight.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the stage iv air mattress was hard, its pump was flashing, and the patient sustained further pressure insult to a preexisting stage 4 sacral pressure injury.The mattress was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: STAGE IV-3 23-SM3000-ARP
• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12373334
• MDR Text Key: 268330867
• Report Number: 1824206-2021-00443
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2021

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: No Information
• Device Model Number: 23-SM3000-ARP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/26/2021
• 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