MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FIRST STEP SELECT; FNM

Model Number 203600

Device Problems Compatibility Problem (2960); Device Handling Problem (3265)

Patient Problem Physical Entrapment (2327)

Event Date 04/11/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for the device family range, we have been able to establish that this complaint is a single, isolated event.No trend is observed for this failure.The product involved in the incident is a first step select mattress replacement system, serial number: (b)(4), model number: 203600 which is a part of arjohuntleigh us rental fleet.The device was rented to the customer (b)(6).Each device in rental fleet need to pass the quality control checks in order to be cleared for dispatch before being placed in the customer facility.The quality control check (qc) for first step select family is being performed in accordance to approved work instruction and covers necessity of checking all device's function and condition.We were able to confirm that this device passed all requirements on 2013-apr-04, before being placed at the customer facility customer technical services issued a service work order (b)(4)) to return the unit to the service center.The first step was returned to a service center on 2013-apr-11.On (b)(6) 2013 the unit was quality control (qc) inspected and met specifications.The service records did not confirm that raised complaint was related to mattress condition or its malfunction.The first step select quick reference guide (#(b)(4)), which is being delivered with each rented device, describes the risks regarding patient migration inherent during the use of specialty bed products that are designed to reduce sheer and pressure on the patient's skin including the risk of gradual movement and/or sinking into hazardous positions of entrapment and/or inadvertent bed exit.In addition caregivers are warned that serious injury or death can result from the use (patient entrapment) or non-use (potential patient falls) of side rails or other restraints.In summary, the device did not fail to meet its specifications, however it was being used at the time of the event for patient treatment, and due to this played a role in the incident.With the limited information provided and the fact that upon the return, the first step select was fully functional, it seems mostly likely that the caregiver either did not attach the mattress properly to the bed frame allowing its migration during the patient placement or the bed frame used did not have correct size for this type of mattress.It was decided to report this complaint based on the potential related with patient entrapment and to be transparent with our current reporting approach.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On (b)(6) 2013, during the initial patient placement, the customer reported that the first step select mattress was not properly placed on the bed frame, causing the patient to fall "into gap".Arjohuntleigh regulatory representative spoke with the patient's nurse who reported that there was no injury to the patient due to the gap between the mattress and side rails.She stated that the patient was not entrapped at any time but would partially slide into the gap and would have to reposition herself.The patient was reported to be on a different mattress and in good condition.The mattress has been returned to the service center the same day.

• Brand Name: FIRST STEP SELECT
• Type of Device: FNM
• 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: 5864435
• MDR Text Key: 52173231
• Report Number: 3007420694-2016-00168
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/10/2016,04/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 203600
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2016
• Distributor Facility Aware Date: 04/11/2013
• Event Location: Other
• Date Report to Manufacturer: 08/10/2016
• Date Manufacturer Received: 04/11/2013
• 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