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

Model Number P136026

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 10/26/2021

Event Type  Injury  

Event Description

Hillrom received a report that an envision blower was not inflating properly and the patient¿s preexisting sores got worse due to laying on the metal bar.The bed 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).

Manufacturer Narrative

Follow up with the customer wound care nurse stated the patient is a (b)(6)-year-old female who was originally admitted from the ed for abdominal pain.Prior to the event it is noted by the customer that she had a pre-existing right buttocks progressive deep tissue injury (dti), 70% red & 30% yellow and black and post the event her injury was listed as unstageable dti, 100% necrotic.The customer states the patient was moved to rehab and discharged home one week after the event.The envision low airloss therapy surface helps prevent and treat stage iii and iv pressure ulcers in patients who weigh between 70lb and 400lb (32kg and 181kg) and are between 4 11 and 6 4(150cm to 193cm) in height.The blower instructions for use warnings include: (1) if the service needed screen shows, call hillrom technical support for assistance as soon as possible, (2) inspection by a hillrom technician noted the lights as yellow and the compressor needing replacement due to wear.The technician states that the yellow light indicates a warning problem with the blower and mattress.This light is located on the lower front of the blower unit and is normally green in color.After replacing the bed is now functioning as designed.If this were to re-occur the bed would alarm (as noted for this event) bringing awareness to the patient¿s care team of an issue and an inspection/ bed swap would occur.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.Deep tissue pressure injuries (dtpi) are persistent non-bleachable 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.An unstageable dti is considered a serious injury for the reasons noted above.Therefore, hillrom is erring on the side of caution and reporting this event due to the serious injury involved.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in august 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the worn out compressor to resolve the issue.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: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12771041
• MDR Text Key: 280464054
• Report Number: 1824206-2021-00530
• 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: 11/08/2021

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 Model Number: P136026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/08/2021
• 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