MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FIRST STEP SELECT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 215200

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration#1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration #3009988881.From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.When reviewing reportable events for first step family range, we have been able to find some complaints with similar fault description, however no trend has been observed.Please note that the performed review revealed that although all complaints had the same effect (patient falling off) there is no one, particular scenario or sequence of events that leads to the patient unintentional exit from the mattress.In the complaint at hand the information was that the patient rolled over in the bed and fell over the side rail to the floor.The mattress involved in the incident is first step select serial number (b)(4), which is a part of arjohuntleigh us rental fleet.The device was rented to (b)(6) medical center.The mattress was checked pre and post placement on (b)(4) 2017 and (b)(4) 2017, respectively and no defect was found.Upon the conducted investigation, it was clarified that the facility's practice of placing overlay on top of the standard mattress and placing patient near or over the top of the side rails could have contributed to the event - patient fall and as a result the patient received nonspecific moderate injuries.The facility was using first step select overlay which was placed over the atmosair mattress and hill-rom advanta frame (non-arjohuntleigh frame).Please note that, the first step select family range includes mattress replacement system (mrs) or mattress overlay with the therapy control unit.Mrs is placed directly on a frame, whereas overlay divided into three sections: head, body and leg, is placed on the standard foam mattress.User manual and quick reference guide provide warning in the 'safety information' section regarding the use of the overlay, mattress and bed frame.The documents state that in order to minimize the risk of fall the bed shall be always in the lowest position when patient is unattended, it is crucial when selecting mattress and overlay combination to "ensure that the distance between top of the side rails and patient surface is at least 8.66 in (220 mm) to help prevent inadvertent bed exit or falls".After the event, the customer who understood that the patient shall be placed in safe position in the center of the surface and that the recommendation given by arjohuntleigh is that a minimum of 8.66in shall be maintained between patient surface and the side rail, decided to no longer use overlays on top of standard mattresses and order appropriate mattresses with overlay to be used with the customer owned frames.Taking the above into account it has been deemed that the root cause of the event is related to the facilities practice while using the overlay and placing the patient on the bed surfaces.In summary, the arjohuntleigh device was being used for patient treatment and placed on the non arjohuntleigh bed frame, therefore it played a role in the event.No failure has been found within the device, the mattress met manufacturer specification.The complaint was decided to be reportable based on the information of patient fall which resulted in an injury.Given the circumstances and that the customer was already informed about arjohunteigh recommendation and will introduce new solutions, no further actions are deemed necessary at this point.

Event Description

Arjohuntleigh was informed that a patient fall out of bed.The patient was using first step overlay and was on a hospital frame.In a result of the fall, the patient received nonspecific moderate injuries, iv line and nasogastric (ng) tube were pulled out.Patient was hospitalized but remained in intensive care unit (icu).Before was placed on the first step select overlay, the patient was sedated and immobile, recovering from a head injury.When the patient recovery progressed, the patient became more coherent and mobile.He rolled over in the bed, and fell over the side rail to the floor.The first step select overlay was placed over the atmosair mattress and customer owned hill-rom advanta frame (non-arjohuntleigh frame).

• Brand Name: FIRST STEP SELECT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6479321
• MDR Text Key: 72332952
• Report Number: 3007420694-2017-00077
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Type of Report: Initial
• Report Date: 04/11/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 215200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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