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 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, 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, evaluation on going.

Event Description

A patient developed stage 4 pressure ulcers while being on bariair bed.

Manufacturer Narrative

Section e1 was corrected with the cleared initial reporter address.The bed was evaluated by arjo service technician who found that some air cushions were worn, they were not holding air.At this moment we are in the process of reviewing information gathered.As soon as investigation is available, a follow-up report will be sent.

Manufacturer Narrative

On (b)(6) 2020 arjo was notified by a customer who was renting bariair therapy system, that a patient developed stage 4 pressure ulcers from below shoulder blades to buttocks while being on the bed.The injury was discovered during regular skin inspection.A treatment included a surgical removal of necrotic tissue and treatment with vacuum seal dressing.The patient was placed on the bed on (b)(6) 2020.The bed was checked by the customer before patient placement.No issue was detected.The pressure on the bed was also checked before delivery on (b)(6) 2020 and the target pressure was achieved.As no discrepancies were identified, the bariair therapy system passed the requirements.The bed was exchanged and a new bed was delivered on (b)(6).When the bed returned from rental it was evaluated and found that 18 out of 23 cushions were not reaching required back pressure.The bariair therapy system user manual (document number 404832-ah) states: ¿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.¿ every shift, air pressure shall be verified performing a hand check: "verify air pressure settings allow 40% depression into cushion where patient lies (¿).Perform hand check to ensure 1.5 to 2 in (35 to 50 mm) of air is supporting patient." immediately after the event, customer receive a guidance how to check the pressure in the mattress using a hand.To sum up, the device failed to meet its performance specification because when the event occurred, air cushions were not sufficiently filled with air.The bed was used for patient¿s treatment and in this way was directly involved in the event.This complaint was decided to be reportable due to serious outcome for the patient.

• 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: 10104220
• MDR Text Key: 194138972
• Report Number: 3007420694-2020-00090
• 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: 07/20/2020

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: 405500-CD-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 06/03/2020; 06/03/2020
• Supplement Dates FDA Received: 07/02/2020; 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 190