MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; IKY

Device Problem Structural Problem (2506)

Patient Problem Pressure Sores (2326)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It was reported that the patient has developed deep tissue injury after 14 days on atmosair mattress.There was one other complaint (b)(4) raised on 2016-apr-27 by the same customer - (b)(6) hospital.In that case the customer voiced that their mattresses were what they describe as: worn out and sagging in the middle.This customer owned over 100 mattresses, bought at the same time (on (b)(6) 2011) and they just reached 5 years of age the same month when the event occurred.They have been used heavily over their life because this hospital had a very high patient census constantly and this customer was about to replace all of them.In this most recent case, despite our best efforts and many attempts, it was not confirmed that the involved mattress had the same claimed malfunction description.It is unknown exactly which device was in use with this patient, therefore its evaluation to verify the product failure was impossible.From information that has been revealed in course of the investigation, it is very likely that despite the mattress was claimed to be worn out and required replacement due to being heavily used, it was still in service, although this information cannot be confirmed with certainty.The instruction for use, which was provided with the device (ifu 407384 b dated on february 2011) in section preventive maintenance schedule states: "preventive maintenance for the atmosair mrs consists of regular cleaning [.] and an overall system check-out to be performed at the intervals described below.All components must be cleaned, disinfected and inspected after each patient's use and before use by a new patient.[.] inspection / system check-out check each of the following before placing the atmosair mrs with a new patient: check mattress surface for tears or cracking; do not use if tears or cracks are present.Ensure mattress is free of stains and is not overly faded.For a and ar models: ensure air inlet hoses and connectors on mattress and pump are clean and undamaged.Ensure pump and power cord are clean and undamaged.Ensure pump hanger brackets are secure and operate correctly.Ensure power switch and comfort control knob both operate correctly.Attach pump to the red rotation hoses and power on to ensure that the mattress surface tilts and there are no air leaks.Attach pump to the blue alternating pressure hoses and power on to ensure there are no air leaks." it is unknown which model was used, therefore it cannot be confirmed if it was powered one (a or ar), but in the previous case of complaint (b)(4) it was model 9000a - therefore we find this section appropriate.No information about preventive maintenance or date of the last device check was revealed.Durability of the atmosair products has been verified and the requirements were gathered in design traceability matrix (document id (b)(4)).In point un-12 user need is specified as 5 years product life.Engineering requirement - design should be able to withstand 50.000 cycles of cornell and hexagonal roller testing.Product passed these tests what leads to conclusion that its design is robust enough.To sum up, the root cause cannot be defined with certainty.Despite our best efforts and multiple attempts, information regarding condition of the mattress was impossible to reach.The device was being used for patient handling at the time of the event and in that way played a role in the event outcome.

Event Description

It was reported that the patient has developed deep tissue injury after 14 days on atmosair mattress.

• Brand Name: ATMOSAIR 9000
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5969460
• MDR Text Key: 55323786
• Report Number: 3007420694-2016-00200
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/22/2016,05/17/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Distributor Facility Aware Date: 05/17/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization