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

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

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).From (b)(6) 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports will be 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).When reviewing similar reportable events for the atmosair family of products, we have been able to find additional (b)(6) 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 ((b)(6)), since it occurred for the second time at this particular customer in the period of last seven months.Based on the information collected to date and the provided problem description, 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 - clorox healthcare bleach germicidal wipes, dedicated for cleaning and disinfection of hard, nonporous hospital surfaces - while the contact of this product with fabrics is to be avoided.The neutral wipes were not used after cleaning with that particular agent.We were able to confirm that the same clorox healthcare bleach germicidal wipes were used for cleaning in the previous issue with the (b)(6) atmosair mattresses reported in (b)(6) 2015 and despite the fact that the formal response regarding cleaning the devices was sent to the customer in (b)(6) 2016, they seem not to follow the manufacturer's advice.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 most likely occurring in both directions.In accordance to the recommendation from the labeling 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.Do not use phenol-based solution or abrasive compounds or pads on the cover during decontamination process as these will damage the surface coating.To disinfect, use only approved disinfectants diluted in accordance with manufacturer's instructions.The atmosair stretched mattress must be disinfect after each patient use.Wipe and rinse any soiling from the mattress surface and base.Use 1000 ppm chlorine or 70% alcohol.Dry surface with towel.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." the conclusion of previous investigation conducted, as well as the information about proper cleaning method and the inspection requirement of the mattresses between the patients (according to safety communication, issued by fda on (b)(6) 2013) were shared with the customer.With the number of new instances reported lately, it seems that no actions were taken and the customer is still using the improper wipes and method to clean the mattress covers.The conclusion of this investigation as well as the information about proper cleaning method will be sent once again to the customer to remind them that proper cleaning of the device is needed to avoid its breakage.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.With the limited information provided it remains unknown if a patient was placed on the mattress when the issue was identified, however there was no adverse outcome reported.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.With the limited information provided it remains unknown if a patient was placed on the mattress when the issue was identified.The issue occured for the second time, and with (b)(6) devices, at the same customer in the period of seven months' time.Additionally provided information revealed that: the facility was cleaning the mattress covers using clorox - bleach germicidal wipes (55%, 1 part solution/10 parts water) per clorox specification, using the solution would break down the material as the solution is meant for solid, non-porous surfaces.It is also highlighted not to use this product with fabrics.The operating manual was available at the facility.The facility protocol is to wipe down the mattress and clean it between each patient.Despite the fact that formal response regarding conclusions of the investigation on previously reported issue with the fluid ingress has been sent to the customer, it seems to still not be followed and inappropriate wipes were still used for cleaning mattress' covers.

• 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: 5815388
• MDR Text Key: 50406119
• Report Number: 3007420694-2016-00140
• 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: 07/22/2016,06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2016
• Distributor Facility Aware Date: 06/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2016
• Date Manufacturer Received: 06/23/2016
• 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): Other