MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIRELITE; INX

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration (b)(4)).From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports will be submitted under registration (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Initially it has been claimed by the customer that the side panel is not staying in the raised position.According to the additionally received information: -the patient used the raised side rail to support herself while turning from side to side in bed.During this time, the side rail unlatched and dropped - patient hurt her elbow as a result -the facility staff, confirmed that formerly the physical therapist had gapped on the raised, locked side rail of the bed to support herself (climb onto the step of the bed), the side rail unlatched and dropped on her knee -neither the patient nor the facility staff required treatment or hospitalization.Fortunately, no injuries were sustained.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for fluidair range, we have been able to found one with a similar fault description compared to the one investigated here: side rail unlatching during use.Based on the collected information, provided description of the event, and conducted evaluation of the device, it has been concluded that the side rail unlatched when downward force was applied to it.Inspection conducted by an arjohuntleigh representative revealed that one of the side rail's latches (the right hand one) had been installed incorrectly - upside down.The latches were also not properly adjusted, and therefore, if someone would pull down the side rail from the inside of the bed, the rail can drop to its downward position.The latch must be adjusted to a height that ensures that it is fully engaged inside the hook latch plate.The fluidair bed is a fluidized bed that has a shape vaguely similar to that of a tub.The role of the side rails is similar to that of any other hospital or care bed, although it should be noted that due to the nature of the bed support and shape, even without side rails, it is not easy to exit without help.Therefore, in actual use it could be suggested that the side rails play less of an role to help avoid unwanted patient exit of the bed.The bed is almost exclusively used as part of the arjohuntleigh rental fleet.The incorrect assembly and adjustment of the latches seems to be the root cause of the claimed failure - side panel unlatched while being used by a patient leaning on it to assist in turning over in bed or similar.The design of the fluidair bed comprises of two side rails, one on each side of the bed.Device labeling requires the care staff to determine, as a first step of preparation for patient placement, whether side rails or other restrains shall be used.In the complaint at hand, from provided description and nature of the claimed issue, it can be concluded that the decision to use the side rail was taken.Please note that side rails are not designed to assist patient's repositioning or support for a caregiver.The bed was being used for patient care, and in doing so, played a contributing role in this particular event.Therefore, we believe it is recommended to inform or remind the customer of the correct use of the device.With regards to the malfunction itself, the incorrect mounting of the side rail latch is considered to be an isolated occurrence that to date was not shown to be part of a trend.The device has been manufactured some time ago and has been in use on and off since without reported issues related to the side rail.However, after our investigation into this event, a review to adjust the wording of our rental quality check guidance for technicians, and preventive maintenance instructions - to include a more detailed instructions on the proper evaluation, check and adjustment of the latch mechanism is being considered.In summary, the device was being used for patient treatment, it failed to meet its specifications (side rail unlatched) and therefore played a role in this event.Fortunately, there were no serious injuries sustained.The event was reported in the abundance of caution.Given the circumstances and the number of products in the market, we shall continue to monitor for any further events of this nature, and do not propose any further action at this time.

• Brand Name: FLUIDAIRELITE
• Type of Device: INX
• 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: 5041603
• MDR Text Key: 24524305
• Report Number: 3007420694-2015-00167
• Device Sequence Number: 1
• Product Code: INX
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Followup
• Report Date: 11/10/2015,08/05/2015

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: No Information
• 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: 11/10/2015
• Distributor Facility Aware Date: 08/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• 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