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

Model Number 630001

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

In the event was involved the auto logic system consist of pump model 630001, serial number (b)(4) and mattress model pxb001dar serial number (b)(4).Analysis of collected information is ongoing.Final conclusions will be submitted as soon as investigation will be completed.

Event Description

An auto logic system was delivered to a hospital to be installed by an arjo rental officer on non-arjo bed frame.Due to lack of empty bed it was decided by the nursing staff to install arjo mattress on the bed (already used by a patient).During placement of the mattress, the patient was not transferred on another bed frame but turned by the nurse to create a free space for the arjo mattress.Then, the patient rolled from the bed frame falling on the floor and suffered unknown injury.

Manufacturer Narrative

San auto logic system was delivered to a hospital to be installed by an arjo rental officer on non-arjo bed frame.Due to lack of empty bed it was decided by the nursing staff to install arjo mattress on the bed (already used by a patient).During placement of the mattress, the patient was not transferred on another bed frame but turned by the nurse to create a free space for the arjo mattress.Then, the patient rolled from the bed frame falling on the floor and suffered unknown injury.There was no arjo system malfunction.No side rails were used on the bed at time of the event.According to warning included in the auto logic instruction for use 630933en ¿do not place the patient on the mattress until it is fully inflated and normal operating pressure has been reached.¿ the installation of the auto logic system was ongoing when the event occurred.There was no arjo device malfunction.The complaint was assessed as reportable in abundance of caution as it may lead to serious health consequences.The patient rolled from the bed frame falling on the floor and suffered unknown injury.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 11788995
• MDR Text Key: 263893556
• Report Number: 3005619970-2021-00011
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784238
• UDI-Public: (01)05055982784238(11)130731
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: 630001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/11/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 04/11/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other