MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. MAXXAIR ETS; IOQ, MAXXAIR ETS

Model Number 310800

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).When reviewing reportable events for the maxxair mattresses range, we have been able to find one additional complaint, related to the patient falling/nearly falling from the mattress.Unfortunately, the circumstances under which the event occurred are unknown - we were unable to confirm if the patient rolled out of the bed - or was trying to stand up from the bed, lost his balance and fell on the floor.Based on the information collected to date, provided problem description and inspection of the device, we have been able to confirm that the maxxair ets mattress was in good working condition and no failure or anomalies have been found within the device.An arjohuntleigh representative who inspected the device just after the event indicated that the left side rail on the hospital's bed frame was lowered.The patient involved in the event had an access to all bed's control and it is assumed by the facility that the resident lowered one of the side rails on her own.In accordance to the recommendation from the user's guide (e.G.310115-ah rev.B) which were delivered to the customer together with the device as part of the labeling, the user is informed that: use or non-use of restraints, including side rails, can be critical to patient safety.Serious or fatal injury can result from the use(potential entrapment) or non-use (potential patient falls) of side rails or other restraints.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 protocols in mind.Caregiver should be consulted and the use of bolsters, positioning aids or floor pads, should be carefully considered, especially with confused, restless or agitated patients.Caregiver should always aid patient in exiting the bed.Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency.In summary, the device was in use at the time of event for the patient treatment and therefore played a role in it.The arjohuntleigh maxxair ets therapeutic surface was in full working condition; the device did not fail to meet its specification.Unfortunately, the patient fell out of the bed and sustained laceration on her face, which required stitching.Although, there was no arjohuntleigh device malfunction, we have decided to report this event in an abundance of caution and to be transparent with the reporting approach.Given the circumstances and the fact that this incident is solely a result of an event beyond the realm of our control, we will continue to monitor any further events of this nature and do not propose any further action at this time.

Event Description

During an arjohuntleigh representative visit at the facility for a different reason, the staff member informed the representative that the patient fell out of the arjohuntleigh's device.It was established that the maxxair ets mattress overlay was placed on top of a customer owned bariatric bed frame (manufacturer unfortunately unknown).

• Brand Name: MAXXAIR ETS
• Type of Device: IOQ, MAXXAIR ETS
• 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: 5309528
• MDR Text Key: 33835003
• Report Number: 3007420694-2015-00233
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/18/2015,12/11/2015

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: No Information
• Device Model Number: 310800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Distributor Facility Aware Date: 12/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2015
• 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): Required Intervention