MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIR ELITE; BED, AIR FLUIDIZED

Model Number 300500

Device Problems Component Falling (1105); Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjohuntleigh was informed that the bed side rail failed and pinched the patient right thumb.The thumb became red.After initial information that the patient had pain, several minutes later he reported that it was "okey".The x-ray was negative.The patient was moved to another bed.It was stated that the side rail latch failed when the patient was using it to hold on while assisting the nursing staff in turning the patient in the bed.

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.From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #(b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(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 initially received could be interpreted as the device not having performed as intended.The investigation has been performed and the conclusion are as follow.Arjohuntleigh was informed that the side rail of fluid air bed failed and pinched the patient right thumb.The thumb became red.After initial information that the patient had pain, several minutes later he reported that it was "okey".The x-ray was negative.The patient was moved to another bed.It was stated that the side rail latch failed when the patient was using it to hold on while assisting the nursing staff in turning the patient in the bed.After the event, the bed was returned to the service center for inspection.A field representative technician could not duplicate the issue, the side latch has not had an indication of wear or damage.The bed was placed back for further customer use, without any repair required.The fluid air 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 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.The patient was holding on to the side rails assisting the nursing staff in turning him in the bed.The side rail failed when the vertical force was applied on the side rails.There are four items that could contribute to the failure of the side rail: the latch could not be properly adjusted and one of the latches was installed upside down.The latch that failed was not the current released version of the latch, the interface surface was flat not the "hook" design.The patient or caregiver could have applied a force of approximately 80 lbs in the downward direction to one side of the previous design side rail thus causing it to fall.Side rails were not locked in full upright position.In this complaint, there is no indication that the side rails latch was incorrectly adjusted or installed upside down.A technician who inspected the device found no damage or wear to the latch.Also information provided by a technician was that the side rail was a recently developed "hook" design, which mean that the first two failures can be excluded.The current design of the side rail latch was tested by applying lateral and horizontal force of 112 lbs and vertical force of 156 lbs.For the latch involved in this complaint, when downward force of 156 lbs.The side rails passed the test when lateral or horizontal force was applied.Therefore, a force of 80 lbs.Applied by a patient as an only plausible root cause can be excluded as well.Quick reference guide and user manual 300510-ah rev.C state that when using side rails, they should be "locked in the full upright position when the patient is unattended" and that upon patient placement completion side rails shall be raised and locked.The complaint states that the side rail failed when the patient was holding on the side rail to assist in repositioning.It may happen that when side rail was not locked properly, due to constant movement, dragging, holding the side rail became unlatched.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 most likely due to being not locked properly in upright position and downward force applied to it.The item number four is therefore considered as contributing factor.When reviewing similar reportable events for fluidair range, we have been able to found two instances where side rail unlatching during use was mentioned.The trend for this failure mode is low.Please note that side rails are not designed to assist patient's repositioning help 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.In summary, the device was being used for patient treatment, it failed to meet its specifications (initial allegation indicated that side rail unlatched) and therefore played a role in this event.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: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• 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: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL ; 98282467
• MDR Report Key: 6510593
• MDR Text Key: 73341789
• Report Number: 3007420694-2017-00091
• 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: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

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: Health Professional
• Device Model Number: 300500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 25 YR