MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. FIRST STEP SELECT

Model Number 215200

Device Problems Device Inoperable (1663); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that the patient with a pressure ulcer on the sacrum area has been using the bed which deflated.With the limited information provided, it is unclear what stage pressure ulcer the patient had, or whether the pressure ulcer was pre-existing, obtained while utilizing the bed or got worsen due to the bed failure.Although none of the information available at this time clearly stated that an arjohuntleigh device has or may have caused the patient condition, if this were to recur it may cause or contribute to a serious injury.

Manufacturer Narrative

(b)(4).As a consequence of issue with the integration of the former kci rental business into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of the complaint being old we have limited information on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations, and implement corrects and corrective actions.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

When reviewing reportable events, we were able to establish that this event is found to be the 3rd one that can be considered similar, within the entire first step mattress system devices range, which represents the failure of mattress deflation resulting in a pressure ulcer or skin breakdown.There is no trend observed for this failure mode.The product involved in the incident is a first step select mattress replacement system, serial number: (b)(4), which is a part of aijohuntleigh us rental fleet.Upon the conducted investigation we were able to confirm that this device passed the quality control on 06/18/2014, before being placed at the customer side.Unfortunately, without having a detailed description of what occurred, we are left to review the limited information received from the customer per our best efforts, and compare it to our product knowledge.The first step select is a pressure relieving overlay and mattress replacement system (mrs) designed to suspend the patient on a low air-loss support surface, providing effective pressure redistribution and early intervention for patients with skin breakdown.The mattress overlay is constructed of a nylon fabric with moisture vapor permeable backing and is divided into three sections.The therapy control unit consists of a single constant speed blower with a warmer to provide air temperatures that can be adjusted for patient comfort.The first step select is indicated for patients who would benefit from a pressure redistribution surface assisting in the early intervention of skin breakdown.Lack of inflation of any mattress cushions might be related either with a failure of electrical components (e.G.: blower malfunction, pump not plugged in) or a failure of mechanical part (e.G.: hose disconnected, cell puncture).With the provided complaint's description it remained unclear what is the actual subject of this complaint.Despite our best effort in gathering the additional information, no more details were provided.Upon the performed review, we were not able to find any history of repair made on this unit.In the quick reference guide(qrg) for first step select(b)(4)), attached to each device, a description of the unit's features is available as well as instruction of how to use them.The system offers an air flow adjustment in order to meet individual patient needs.There is also an x-firm option available which allows the quickest inflation to ensure the firm surface during the patient transfer.Moreover, the qrg warns the user about necessity of regular skin care, which includes checking the patient skin conditions on regular basis.From qrg (((b)(4)): "skin care - monitor skin conditions regularly, especially bony prominences and areas where moisture or incontinence may occur or collect, and consider adjunct or alternative therapies for high acuity patients.Early intervention may be essential to preventing serious skin breakdown." based on all information available, we were not able to establish the exact root cause and sequence of events which have led to the issue covered by this investigation.Having in mind the design of this device and fact that the allegation regarding actual device malfunction has not been confirmed, it seems most likely that the issue raised by the customer was related with incorrectly set air flow, rather than an actual device malfunction.In summary, the received but not confirmed allegation is that the bed failed to meet the manufacturer specification and was not working as per its design.Arjohuntleigh has received an information that the patient with a pressure ulcer on the sacrum was using the bed which deflated, therefore, it has been assumed that our device has played a role in the incident.Although none of information available at this time suggest that an arjohuntleigh device has or may have caused the patient condition, due to the lack of information about what has actually happened, we cannot confirm that upon the recurrence this would not cause or contribute to a serious injury.In spite of that, we decided to report this event to competent authorities to ensure that we are as transparent as possible in our reporting approach.The exact root cause of this issue could not be established.Given the circumstances and the fact that there is no trend observed for customer complaints with this failure mode, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: FIRST STEP SELECT
• 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 ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4652077
• MDR Text Key: 5681278
• Report Number: 3009988881-2015-00024
• 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: User Facility,user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

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: Other
• Device Model Number: 215200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• 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