MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number KA9SONB3478

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient fell from the arjohuntleigh mattress.The mattress was placed on a non-arjohuntleigh bed frame.The bed frame was identified as bed manufactured by medicraft (b)(6) in 2007, serial number (b)(4).No further circumstances of the event has been provided, thus far.We report this event due to a patient fall and based on potential for a serious injury.

Manufacturer Narrative

Please note, that we have learned that the bed frame had no side rails raised "due risk of climbing over and considered as restraint (no restraint policy)." the fall was unwitnessed.The investigation is still in progress.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjohuntleigh was informed that on 2017-12-29 a resident (male; age: 80; weight 61.7 kg, height 165 cm) fell from a non-arjohuntleigh bed frame and placed on it an arjohuntleigh atmosair9000 mattress the first night the mattress was installed.The mattress was delivered to uniting lilian wells north parramatta on 2017-12-22 and was placed on a medicraft bed model hle9000m, serial number 10814 (out of 10 mattresses only this one was placed on the medicraft bed).The fall was unwitnessed, the resident was found on the ground with lump on left forehead causing bruising around eye.Medical treatment involved first aid and the patient was reviewed by general practitioner.No hospitalization was required.The resident was classified as a- albert in accordance to arjo mobility gallery classification, which means that the resident was able to perform daily activities independently without assistance from another person.It was indicated by arjohuntleigh technician who visited the customer after the event, that the bed side rails were not used "due to risk of climbing over and considered as restraint (no restraint policy)" and the bed frame was in the standard height (as described by an arjohuntleigh technician).Daughter's resident expressed a concern that before the incident, she noticed that when a backrest was raised the sheet slipped from the mattress.The additional concern was that when a resident was transferring from the mattress, he seemed unbalanced at the edge of the bed.These concerns were viewed in depth.The mattress was inspected by a technician and no fault was found.An arjo key account manager stated that when the mattress laid on a flat surface in the center of the mattress the sides lifted about 2-3 cm (0.79 - 1.18 inch), also when a volunteer laid on the mattress surface and rolled to side, the mattress side lifted.The key account manager also stated that the sheet seemed slide on the mattress cover.In order to further verify these findings, we have contacted arjo contract manufacturer and additionally we have checked other mattress from atmosair family products to double-check if the reported issue is normal mattress behavior.The atmosair stretcher was placed on a flat surface at responsible manufacturer site.It was noticed that the mattress had both sides slightly raised about 3 cm (1.18 inch) without weight.Then a weight (53kg (117lbs)) was applied on the mattress and again the elevation was measured and it was about 2 cm (1.18 inch), when a volunteer was moved to the mattress side, the mattress lifted about 3.5 - 4 cm (1.38 - 1.57 inch).Information we have received from our contract manufacturer was that: the sides lifting about 2-3 cm (0.79 - 1.18 inch) is per the design.When placing a weight on a mattress, the sat system will adjust after 15-20 min.The fabric soflux with non-skid bottom used for this mattress, was designed in a way to reduce sheer forces from a patient laying on it.From the above, it can be stated that an information about top cover being slippery when backrest is elevated most likely relates to the individual impression.The alleged unbalanced of the mattress because of sides lifting cannot be confirmed either.The results obtained confirmed that the described lifting is a normal mattress functionality and with comparison to australian service unit findings, the results are similar.Please note that the atmosair 9000 is a hybric mattress built of sat cells (made of foam) and encompassed by top foam layer.The sat cells are a higher profile than the foam shell, therefore it is normal mattress behavior to have raised sides.Additional observation made by arjohuntleigh technician during customer visit was that only the involved mattress was placed on the medicraft bed and that this bed does not have mattress keep handles "so the mattress could easily slide or move on bed mattress platform".The mattress cover bottom is built of non-skid fabric, which minimize mattress movements on a bed platform, thus it is unlikely that the mattress will slide.The bed frame used with arjohuntleigh mattress was described by arjohuntleigh technician as an old medicraft bed.We have not received additional information regarding the bed dimension, no photographs that would show the bed frame platform or side rails being in low and high position, also our search through the website did not give any results, thus we cannot verify if the mattress selected was compatible with the medicraft bed frame.However taking into account additional information from the key accountant manager that the customer ordered new mattress suitable for new bed frame, it can be assumed that the mattress selected for medicraft frame was incorrect, therefore impression of unbalanced.User manual states: - "patient migration - specialty surfaces have different shear and support characteristics than conventional surfaces and may increase the risk of patient movement, sinking and/or migration into hazardous positions of entrapment and/or inadvertent bed exit".- "safety information.Side rails / patient restrains - whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocol in mind.[.] consider not only the clinical and other needs of the patient but also the risk of fatal or serious injury from falling out of the bed and from patient entrapment in or around the side rails, restraints or other accessories".[.] it is recommended that side rails (if used) be locked in the full upright position when the patient is unattended." - "bed frame - always use a standard healthcare bed frame with safeguards or protocols that may be appropriate.It is recommended that bed and side rails (if used) comply with all applicable regional and local regulations and protocols.Frame and side rails must be properly sized relative to the mattress to help minimize any gaps that might entrap a patient's head or body." - "bed height - to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended".- "head of bed elevation - keep head of bed as low as possible to help prevent patient migration".The investigation confirmed that atmosair9000 mattress can be excluded as a potential factor or the resident fall.Information provided in the complaint stated also that the side rails were not used, the bed was not in the lowest position when the patient was unattended and the facility did not have restrain policy.This on its own create a hazardous situation.From the above, it seems that the safety protocol was not followed by the customer, which resulted in patient fall.In summary, the mattress was being used for patient treatment at the time of the event and in that way played a role in the event outcome.The mattress did not fail to meet its performance specification, the resident fall was not a result of mattress failure but lack or not followed safety protocol in terms of risk assessment for using or non-using side rails.We report this incident because of the resident fall and potential for a serious injury or death.

• Brand Name: ATMOSAIR 9000
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• MDR Report Key: 7236697
• MDR Text Key: 98986203
• Report Number: 3007420694-2018-00027
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KA9SONB3478
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 03/19/2018
• Supplement Dates FDA Received: 03/02/2018; 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 62