MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIAIR; IOQ

Model Number 404000

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Handling Problem (3265)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

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 (there was no allegation of that), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for (b)(4) devices, we have been able to find records with similar fault descriptions compared to the situation investigated here, patient fall from the bed.There is no trend observed for this failure mode.The product involved in the incident is a (b)(4) therapy system, model number: 404000, serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet and was rented to the customer ((b)(6) center).Each bed in rental fleet needs to pass the quality control checks in order to be cleared for dispatch before being placed in the customer facility.The (b)(4) bed quality check process requires inspection of all device components and functions according to the current instruction.(b)(4) bed is a front exit, bariatric therapy system designed to help prevent skin breakdown, while helping to manage risks associated with patient care.The patient placement in the bed as well as exit is being held through a foot entry, in which patients are required to be placed in a standing position to enter and exit the bed.All the adjustments of the bed assembly are electronically controlled by 2 control panels: the main controller corner post allows the ability to modify the therapy settings as well as the position of the bed.The main control panel/display is located on the adjustable corner post of the bed and faces outward.It is not physically accessible by the patient.The hand control pendant allows the patient to change the head, foot, and trendelenburg positions of the bed themselves.The quick reference guide ((b)(4) rev.C) attached to each device, instructs that the patient exit button located on the main control panel must be pressed and held until the foot board stops moving and is almost on the floor mattresses (including the patient back support) will automatically deflate as head angle becomes greater than 15 degrees and reverse trendelenburg is greater than 3 degrees.The document also warns that caregiver should always aid patient in exiting the bed.Additionally the patient exit button should always be used to properly position the bed and then assist the patient.The hand control pendant was designed to allow the patient to change the adjustments of the bed into a comfortable position.This controller also allows the patient to replicate the patient exit position; however, the patient back cushion does not automatically deflate as the bed tilts forward and concaved upper leg support does not occur for secure patient exit.This may increase the probability of unintentional exit.The foot end of the bed is being secured by the footboard which in some cases might be released by facility staff during patient placement.Nevertheless, the qrg warns the user that such activity may potentially increase risk of injury by making it easier for the patient to slide out of the bed, over the footboard and onto the floor.It is recommends that two caregivers, one on each side of the patient must be present to assist the patient to a standing position.Additional caregivers may be needed, depending on weight and mobility status of the patient and institution protocol.The main control panel was designed for the caregiver usage.In summary, based on the investigation performed above we were able to establish that there was no problem found with the device that could have led to the patient fall.Therefore, an actual device malfunction could be ruled out.Based on all gathered information it seems most likely that the patient fell out of the bed as a result of attempt to exit the bed while unattended.The root cause of the event occurrence is related with user not following instruction given by manufacturer which, when followed, ensure a safety patients egress from the bed platform.Although the device did not fail to meet its specifications, it was being used at the time of the event for patient treatment and due to this played a role in the incident.Complaint was decided to be reportable based on the potential related with fall and to be transparent with the reporting approach.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Initially, we have been informed that the patient slid down to the middle of the (b)(4) bed and then down to the floor.Facility staff requested an arjohuntleigh representative to visit and assess the bed as they got the feeling that it might not be stable.From additional information provided we concluded that: the patient accidentally pushed the wrong control button on the remote handset causing the bed to go into the chair position and then slid out the bottom.Neither the patient nor the caregiver were injured during this event.Facility staff confirmed there was nothing wrong with the bed.

• Brand Name: BARIAIR
• Type of Device: IOQ
• 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 78219 ; 2103170412
• MDR Report Key: 5311334
• MDR Text Key: 33896852
• Report Number: 3007420694-2015-00238
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/18/2015,08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Distributor Facility Aware Date: 08/14/2014
• Event Location: Other
• Date Report to Manufacturer: 12/18/2015
• Date Manufacturer Received: 08/14/2014
• 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