MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AURA LOGIC CUSHION; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

This medwatch report is submitted under arjo (suzhou) co., ltd.Establishment name and registration # 3005619970.An investigation was carried out for this complaint with the following conclusions: arjo was informed about a patient fall while using an aura logic seat cushion.Customer reported that patient was not injured from the fall and that the incident was not caused by arjo device.Arjo contacted the customer to gather additional information.It was stated that the incident did not happen currently, therefore, there were no details about the device model and serial number as well as no clarification regarding the cause of the patient fall.The customer was only requesting an instruction for use (ifu) for clarification if anything can be put on top of the seat cover.As per product ifu, aura logic seat cushion have integral tubeset and cover.The cushion are not to be used without a protective top cover.Ifu guides through correct seat cushion installation depending on the type of the chair, it indicates to place protective cover over the seat cushion.It also clarifies that "placing extra layers between the patient and the mattress potentially reduces the benefits provided by the mattress and should be avoided or kept to a minimum".Because no additional information was provided, the root cause of this incident remains unknown.In summary, the autologic seat cushion was used by the patient when the event occurred and from that perspective it played a role in the incident, however no failure was reported.It was indicated by the customer that the fall was not related to the arjo seat cushion.We report this incident in abundance of caution because of patient fall.

Event Description

Arjo was informed about a patient fall while using an aura logic cushion.Customer reported that patient was not injured.

• Brand Name: AURA LOGIC CUSHION
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; jiangsu; suzhou, 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; jiangsu; suzhou, 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 9244725
• MDR Text Key: 219386031
• Report Number: 3005619970-2019-00017
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Type of Report: Initial
• Report Date: 10/28/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• 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): Other