MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. BARIAIR; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 405500-CD-R

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #(b)(4)).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon investigation conclusion.

Event Description

A patient developed stage 3 pressure ulcer while being on bariair bed.Customer stated they found that an air cushion in the upper section was not filled with air and the patient was laying on the bed platform.

Manufacturer Narrative

On 29th of october 2019 arjo was notified about bariair therapy system malfunction: some cushions of the upper body part of the mattress were not filled with air.According to information provided by the customer staff, the bariatric patient was placed in the bairair system on (b)(6) 2019.4 days later, on (b)(6) , the patient was transferred to another bed for surgery.A small area of swollen skin with little redness was noticed on his back.The staff initially assumed that this was effect of the transfer process.After the surgery, the patient was placed in the bariair again.In the following days, affected skin area enlarged and developed into a stage ii pressure ulcer, which deteriorated into a full thickness wound during the night from (b)(6).The bariair therapy system is a risk management treatment system designed for large and/or difficult to manage patients.The system provides low air-loss pressure management therapy, pulsation, percussion, turn assist, flexible for patient positioning capabilities and built-in scales for patient weighing 300 to 850 lb (136 to 386 kg), including accessories.The bed involved was used for a bariatric patient.It was identified as bariair, model number: 405500-cd-r and serial number (b)(6), part of arjo rental devices fleet.The bed passed quality control requirements before shipment to the customer and no failure was found.According to the information provided by the facility staff and device checks conducted after the event, air cushions located under patient's back were not sufficiently filled with air.This was caused most likely by the hose improperly inserted to the air cushion.It is unknown if air hose has been not sufficiently inserted to air cushion or it became loose during use with the patient.According to the intensive care unit manager, the cushion deflated enough to lead to the situation that the patient's back was supported by the bed frame.Insufficient support for the patient's back was noticed after 7 days from the patient's placement.Bariair therapy system user manual (document number (b)(4)) informs that after patient placement, a hand check beneath shoulders, hips and heels should be performed as follows: [.]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." another factor that influenced severe injury sustained by the patient was difficulty of patient repositioning or transfer due to his medical condition and unavailability of another appropriate bed.Bariair user manual gives the following guidelines: "skin care - monitor skin conditions regularly, particularly at bony prominences and in areas where incontinence and drainage occur or collect, and consider adjunct or alternative therapies for high acuity patients.Early intervention may be essential to preventing serious skin breakdown." to sum up, several factors influenced patient injury outcome: not detected insufficient pressure in some upper body cushions, inability to reposition the patient, patient medical condition, inability to transfer the patient to other bed.When the event occurred, an air cushion was not sufficiently filled with air, what indicates that the device failed to meet its specification.It was used for patient's treatment and in this way played a role in the investigated event, however inappropriately inserted air hose into the air cushion, on its own, is not considered a reportable failure.This complaint was decided to be reportable due to serious outcome for the patient.

• Brand Name: BARIAIR
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 9375297
• MDR Text Key: 175836827
• Report Number: 3007420694-2019-00207
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Report Date: 12/20/2019

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: Other
• Device Model Number: 405500-CD-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 153