MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ATMOSAIR STRETCHER; IKY

Model Number KSDTNB3076

Device Problems Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that this report is being submitted as an effect of request for an exemption, which was sent to fda on 2016-01-28.The fda responded on 1st feb 2016 with a suggestion that we should continue to submit individual adverse event reports on these devices in accordance with the requirements in 803.50(a), 803.52 and 803.12(a).As a consequence the separate 25 records needs to be opened and reported individually.When reviewing similar reportable events for the atmosair family of products, we have been able to additional 25 complaints with fault description similar as the one investigated here: bodily fluids ingress inside the mattress, leading to the situation in which it became possible for a next patient using the contaminated device.The issue however seems to be isolated to one, particular customer.Based on the information collected to date, the provided problem description and the inspection of the devices, we have been able to confirm that the atmosair mattresses' covers were damaged.Further investigation of the issue revealed that the facility was using a cleaning agent dedicated for cleaning and disinfection of hard, nonporous hospital surfaces - while the contact of this product with fabrics is to be avoided.In addition, the used concentration of the agent was too high.It was stated by the facility that the proportion: 1 part of solution to 10 parts of water was used while the mattress labeling indicate that the concentration shall be 1: 100.The neutral wipes were not used after cleaning.It has been deemed that the incorrect cleaning procedure lead to the breakdown of the cover's material, which further lead to the ingress of fluid inside the mattress.The permeation of fluids from the inside of the mattress to the outside is lower than in the opposite direction.However with this level of cover damage it was occurring in both directions.In accordance to the recommendation from the labeling (e.G.#407308-ah rev.A) which was delivered to the customer together with the device, the user is informed about the usage and cleaning of the mattress: during the preparation for use, the mattress surface shall be checked for tears or cracking.If any is present, the device should not be used.For regular cleaning, use a mild detergent with water on a non-abrasive cloth.To disinfect, use only approved disinfectants diluted in accordance with manufacturer's instructions.The atmosair stretched mattress must be disinfect after each patient use.Disinfect clean surface with a chlorine solution mixed to proper concentration, 1:100 (two ounces of chlorine bleach to one gallon if water).Using a clean cloth, wring out excess chlorine solution until cloth is damp.Wipe entire surface with damp cloth.Check each before using the mattress with a new patient that the mattress surface is free from tears or cracking.Do not use if tears or cracks are present.Ensure that the mattress is free of stains and soiling - clean and/or disinfect as required.Therefore the conclusion of this investigation, as well as the information about proper cleaning method and the need of inspection of the mattress between the patient (according to safety communication, issued by fda on 19 apr 2013) are to be shared with the customer.It seems also to worth noting, that the atmosair stretcher mattress' foam includes anti-bacterial and anti-fungal agents.Nevertheless, it had been decided to report this event in the abundance of caution and to be transparent.In summary the device failed to meet its specification as it suffered a malfunction due to use error.The mattress has not been taken out of service, however with the limited information provided it remain unknown if a patient was placed on the mattress when the issue was identified.Fortunately, there was no adverse outcome.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

It has been claimed by the customer that the mattress cover leaked through, and mattress had built up fluids.The mattress has not been taken out of service, however with the limited information provided it remain unknown if a patient was placed on the mattress when the issue was identified.Additionally provided information revealed that: the facility was cleaning the mattress covers using two methods - one with (b)(6) - leach germicidal wipes (55%, 1 part solution/10 parts water), and the other method was with the solution (65%, 1 part solution/10 parts water) and staff did not use a neutral wipe afterwards for either method - per (b)(6) rep, using the solution would break down the material as the solution is meant for solid, non-porous surfaces; the facility has also found during staff interviews that one staff member did not want to use the wipes and preferred to use the solution.The operating manual was available at the facility.The facility protocol is to wipe down the mattress and clean it between each patient.The bodily fluids found inside the mattress were from the previous patient or patients.

• Brand Name: ATMOSAIR STRETCHER
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5576474
• MDR Text Key: 42772376
• Report Number: 3007420694-2016-00055
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/14/2016,11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KSDTNB3076
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2016
• Distributor Facility Aware Date: 11/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2016
• Date Manufacturer Received: 11/18/2015
• 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): Other