MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ATMOSAIR 4000

Device Problems Inflation Problem (1310); Leak/Splash (1354); Defective Component (2292)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

(b)(4).

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 kinetics concepts in.(under registration #1625774).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 #3009988881.When reviewing reportable events for the atmosair 4000, we were able to establish that this is a 3rd complaint regarding the allegation of mattress bottoming out, where the pt suffered an injury.There is no trend observed for reportable complaints with this failure.With the complaint at hand we received an allegation that a pt developed a 3rd stage pressure ulcer on the right ankle after having been placed on the atmosair 4000 mattress.The device involved in this incident has been examined by a nominated technician.The foam inside the mattress was found to be damaged and dirty.The cell assembly envelope was very badly torn, the sat valve was in place.The cover was examined closely and there was a small hole in the cover noticed.When a 20 kg weight was applied to the middle of the mattress over a period of 3 hours the mattress bottomed out and it was found that air was leaking around the non-return valve tubing.The design of this device is that there is a form part in which a sat (self adjusting technology) system is placed.Such design ensures that even if the part of the mattress exhibited a depression the pt is still being supported by the mattress foam.It has been confirmed that there is no significant difference between pressure mapping for correctly working mattress and a mattress with failure raised by the customer.The sat system does not extend to the entire length of the mattress resulting in the ankle/heel area being supported by foam only.The found tubing leaks would not affect the foot section, therefore it could not have been a contributory factor in the pt outcome (issue has been located in the seat section of the mattress while the pt suffered pressure ulcer on the ankle).It is also worth noting that we are not aware of the pt's pre-existing medical condition before she was placed on the atmosair 4000.Taking into the consideration that this mattress is indicated for prevention or treatment of skin breakdown, we cannot rul out the possibility that pt already had a pressure ulceration at the ankle prior to actual usage of our device.In summary, when t eh event occurred, the device was being used for the pt treatment, therefore, it played a role in the event.Due to the found failures it has been determined that the device did not meet the manufacturer specification but it has been confirmed that, by the design and the nature of found malfunctions, no found malfunction could have been a contributory factor in the pt outcome - 3rd stage pressure ulcer on the right ankle.Nevertheless, it was decided to report this event in our approach to be as transparent as possible.Given the circumstances and the fact that there is no trend observed for reportable complaints with this failure, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ATMOSAIR 4000
• 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 rd; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4848103
• MDR Text Key: 5811454
• Report Number: 3007420694-2015-00127
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66