MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED, FLOTATION THERAPY, POWERED

Model Number P136026

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/02/2022

Event Type  Injury  

Event Description

The customer reported that the screen on the envision blower was not readable, the patient was sinking into the middle of the mattress and developed bilateral heel deep tissue injuries as well a small preexisting sacral unstageable pressure injury that increased in size to 4x2.The patient is a 93 year-old man admitted for cva and described to be very thin.The pressure injures were treated with santon (sacral) and betadine (heels).This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported that the screen on the envision blower was not readable, the patient was sinking into the middle of the mattress and developed bilateral heel deep tissue injuries as well a small preexisting sacral unstageable pressure injury that increased in size to 4x2.The patient is a 93 year-old man admitted for cva and described to be very thin.The pressure injures were treated with santon (sacral) and betadine (heels).During a follow up call with the customer, the customer stated upon entering the room she was aware of the ambient noise of the bed's blower, but noticed the patient was sunken into the middle of mattress, when attempting to check the device's setting, the caregiver stated the screen was unreadable due to lines running through the screen.The blower was powered off and back on and reportedly alarming.The device was then removed from the bed and replaced with a different blower.The customer could not recall the alert that was provided by the device.The envision low airloss therapy surface helps prevent and treat stage iii and iv pressure ulcers in patients who weigh between 70 lb and 400 lb (32 kg and 181 kg) and are between 4 feet 11 inches and 6 feet 4 inches (150 cm to 193 cm) in height.The bed is equipped with an alert system that generates different alarms to notify the caregiver of potentially hazardous conditions with the intention that the caregiver will respond to the alert and take appropriate action to rectify the issue.An inspection of the device by a hillrom technician notes that upon arrival for inspection the technician found the device's blower screen on with no active error codes and that the patient's nurse reports no issues with the bed.No repair was needed 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.Ulcers covered with slough or eschar are unstageable.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.Although the blower was found to be working as designed, the report of a deep tissue injury meets the definition of serious injury and is therefore considered a reportable serious injury.Based on this information, no further action is required.

• Brand Name: ENVISION BLOWER KIT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 15173605
• MDR Text Key: 297313146
• Report Number: 1824206-2022-00349
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2022

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 Model Number: P136026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/05/2022
• 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