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

Model Number M6257763-R

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4) was notified that a paraplegic patient after a herniated disc with prominent trochanters developed pressure ulcer while being on therakair visio.The patient was transferred from another hospital with already existing stage 4 pressure ulcer in sacral area.It was reported that after 3 weeks on therakair visio, the patient developed another stage 4 pressure ulcer in lateral position.The system was checked by (b)(4) service personnel and no bottoming out of the mattress was noticed, the pressure in the system was within the manufacturer specification.

Manufacturer Narrative

Investigation has been performed and the conclusions are following.On 6 mar 2019 arjo was notified that a paraplegic patient (female, 55 years old, 70 kg) after a herniated disc with prominent trochanters developed stage 4 pressure ulcer on uncer trochanter, after 3 weeks of therapy on therakair visio mattress.The patient was transferred from another hospital with already existing stage 4 pressure ulcer in sacral area.The customer stated that arjo mattress bottomed out and patient developed pressure ulcer when in lateral position.The customer performed their own pressure measurements, but did not provide further interpretation, thus it is impossible to draw some conclusions from the measurements.The system was inspected in arjo service center.In order to simulate if the lateral position may influence the air flow, the mattress was tested by load application of 70 kg.A hand-check test was done according to user manual 340750-ah rev e: "perform a hand check to verify sufficient support: slide your hand flat between the mattress foam base and the cushions to verify a 2.5 cm to 4 cm clearance".No sinking was found.The system was left to run for 24 hours.No change, values were stable.The system has successfully passed the functional check upon inspection.User manual states: "monitor skin condition regularly and consider adjunct or alternative therapies for high acuity patients.Give extra attention to any possible pressure points and location where moisture or incontinence may occur or collect.Early intervention may be essential to preventing skin breakdown"."when adjusting the patient position (e.G.From fowler's position to supine) the firmness setting may need to be readjusted".Taking the above into account, it can be concluded that the therakair visio did not fail.A pressure ulcer management protocol shall be performed, including repositioning, nutritional support, regular skin care.Not following the therapy regimen may be a factor in developing stage 4 pressure ulcer.It is possible that when the patient was in lateral position, the firmness setting was not readjusted, however this cannot be confirmed.The reported event is a singular occurrence.In summary, no technical malfunction was detected, but the system played role in the incident as was used during patient treatment.

• Brand Name: THERAKAIR VISIO
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 8472788
• MDR Text Key: 140596382
• Report Number: 3005619970-2019-00005
• 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: 05/02/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: M6257763-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2019
• Distributor Facility Aware Date: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 70