MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB AURA CUSHION; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Device Maintenance Issue (1379); Material Separation (1562)

Patient Problem Hip Fracture (2349)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh was informed about an incident which occurred during the use of aura seat cushion.It was indicated that the cushion came away from the chair causing the patient to fall and land with her right leg under the left one.As a result, the patient has suffered from a hip re-fracture.

Manufacturer Narrative

(b)(4).The investigation was completed and the conclusions are as follow: review of reportable events for aura cushion, revealed that there are no records for this device.The incident is the first one reported to us associated with the patient fall.The product allegedly involved in the incident was aura cushion with serial number (b)(4).The product was used by the customer (b)(6) hospital.The aura® system is an alternating pressure relief system which consists of a pump and seat cushion.The system can be used on standard hospital and normal domestic chairs.Intended use of this product is to prevent and/or manage pressure ulcers for patient up to 120 kg (264lbs).Aura cushion is not intended for patients with unstable spinal fractures.Aura cushion is made of cells which are encompassed in base cover and covered by top cover.Cushion overlay has buckle straps on each corner of the cushion, which are used to attached the cushion to the chair.Initially, arjohuntleigh became aware of the incident with a resident that fell from aura cushion and in a result sustained an injury - re-fracture of hip.Later on we have been informed by the customer that "the incident record indicates that this cushion did not cause this patient's fall as it was not being used at the time," the customer however did not indicate what type of device was used when the incident occurred.Based on the photograph provided by the customer, it was deemed that aura cushion failed with the straps being separated from the base, however aura cushion did not cause or contributed to the adverse event and the detached straps are not related to the reported incident.We have not been able to collect more details regarding the failure, however it was possible to list some factors that may influence strap damage: the straps may get damage intentionally or by accidental misuse as a result of improper handling and not following the instructions provided in instruction for use (ifu), such as exceeded patient weight or improper cushion's installation process.The straps may be incorrectly used to relocate the cushion, secured to the frame too tightly which initiates the tearing process, any sharp elements under the cushion while placing it on the chair could perforate the base sheet, excessive force used while pulling the straps may initiate tearing even after a short time in use.Over the time, stretching, stringing, pulling the strap while attaching in to the chair may result in stitching failure and separating from the base cover.For this reason the most probably root cause of the strap failure has been deemed normal wear and tear.The strap malfunction is very likely to be discovered before the usage, during cleaning process and cushion examination between patients or during cushion installation.The damaged cushion has to be excluded from use and cannot be used again, which mitigates the risk of hazardous situation.In summary, the event has been assessed reportable based on the initial allegation that the arjohuntleigh cushion might have contributed to the event.Further clarification from the customer was that the aura cushion was not involved in the incident as it was not used that time.Basing on the provided photographs it was determined that the cushion failed to meets its specification as the straps separated from the base cover, however the failure is not related to the incident as the cushion was not used for treatment or diagnosis of the patient when the event occurred and was not directly involved in the reported incident.Upon conclusion from the investigation it was deemed that aura cushion did not cause or contribute to the adverse event and it is unlikely that this type of malfunction may results in an adverse outcome if the user follows every recommendation given in instruction for use.Therefore, this type of failure is not considered safety related and will not be reportable to competent authorities in the future.Device did not contribute to the event.

• Brand Name: AURA CUSHION
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 698 282 46
• MDR Report Key: 6331292
• MDR Text Key: 67437645
• Report Number: 3005619970-2017-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: Other Caregivers
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2017
• Distributor Facility Aware Date: 01/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2017
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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