MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIAIR; BED, FLOTATION THERAPY, POWERED

Model Number 405500-CD-R

Device Problem Decrease in Pressure (1490)

Patient Problem Pressure Sores (2326)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon investigation conclusion,.

Event Description

A customer reported that their patient developed a deep tissue injury while using bariair bed.The customer stated that the bed had not enough air in the cells.Initial device assessment indicates a motor failed and overheating.

Manufacturer Narrative

During an evaluation it was found that the air distributor located in the pump had a crack.The pump was compensating the air pressure in the mattress, but because of the crack the mattress might have been seen as having less air.A supplementary report will be provided when conclusions from investigation are available.

Manufacturer Narrative

A customer reported that their patient sustained a deep tissue injury while using bariair bed.It was reported that the cushions seemed to have less air.The bed evaluation revealed that the sub-assy valve (air distributor) was cracked.The blower was operational and was still pushing the air to the mattress (because of some air loss, the blower was working harder) but because the sub-assy valve was cracked the mattress might have been seen as having less air.Customer allegation was confirmed.As per the customer report, this patient was hospitalized at covid icu, was placed in prone position and since (b)(6) 2020 the patient was not repositioned due to deterioration of health.No information about pre-existing pressure ulcers was provided.There are several factors which may lead to formation of pressure injury: impaired mobility, skin moisture or microclimate, poor nutrition, obesity, health conditions (skin damages, chronic wounds, acute injuries, surgical recovery, chronic illnesses, medication use ), etc.This patient weight was 185 kg and was classified as emma, according to arjo mobility gallery.This means that the patient was immobile.Priority for emma patients is to provide optimum care and/or preventing complications due to immobility, e.G.Good skincare.The goal for emma patient is to avoid complications caused by long-term bed confinement and make the patient as comfortable as possible.Because of patient serious health condition, a proper skin monitoring and repositioning might have been impossible.In accordance with pressure ulcer system prevention points (npuap), impaired mobility is considered the primary factor associated with pressure injury formation.The more factors occur for the patient, the more likely they will develop pressure injuries.Bariair user manual in section 'safety information' indicates how important is to monitor skin conditions regularly.It states to consider adjunct or alternative therapies for high acuity patients and that early intervention may be essential to prevent serious skin breakdown.It states also to regularly perform a hand check to verify the air pressure adjustment in the mattress: "perform a hand check beneath shoulders, hips and heels [¿]: slide hand under cushion sleeve to rest on cushion support.Lift hand slightly to verify 1.5 to 2 in (35 to 50 mm) of air is supporting patient".Based on the above, we did not find a correlation between a sub-assy valve failure and formation of deep tissue injury in this patient.The bariair bed was used for the patient treatment when the deep tissue injury was noticed and therefore played a role in the event.The bed failed to meet its performance specification since there was a sub-assy valve failure found but the failure did not lead to pressure injury.This patient health profile could be particularly exposed to formation of skin ulcers/skin breakdown.

• Brand Name: BARIAIR
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 11054703
• MDR Text Key: 225807079
• Report Number: 3007420694-2020-00194
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 405500-CD-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 11/25/2020
• Supplement Dates FDA Received: 01/21/2021; 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 185