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

Model Number 630001

Device Problem Device-Device Incompatibility (2919)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Arjo became aware of an event involving an arjo auto logic system and non-arjo bed frame (casa med classic low).It was claimed by the customer representative that a patient fell from the mattress over the raised side rail.The mattress was allegedly 1.5 inches (3.8cm) too high.The bump on the patient's head was reported as an outcome of this event.An ambulance was called but after the patient's assessment, a transfer to a hospital was deemed unnecessary.The pump and the mattress were inspected by an arjo representative and no faults were found.The system met the performance specifications.No mattress over-inflation was found.A rental supervisor visited the facility.At the time of the visit at the customer site, anything additional (pillows, stuff) that would cause the patient to fall out of the bed was observed.Arjo received access to the non-arjo bed frame instructions operating manual (casa med classic low, 19749gwbe).This document includes information about the allowed dimension of the mattresses that can be used with this bed frame.The allowed height of the mattress equals 12cm.The height of auto logic mattress equals 20.5cm.Comparing this data, it was concluded that the arjo mattress was too height (exceeding the allowed height of the mattress).In a result, the insufficient distance between the top surface of the mattress and the top of the side rails occurred and the patient fell over the closed side rail.The arjo mattress involved in the event met performance specifications however it was incompatible with the non-arjo bed frame.The patient fell from the arjo mattress, therefore, the arjo product was directly involved in the reported incident.The complaint was assessed as reportable due to the patient fall from the mattress what resulted in injury.

Event Description

Arjo became aware of an event involving an arjo auto logic system and non-arjo bed frame (casa med classic low).It was claimed by the customer representative that a patient fell from the mattress over the raised side rail.The mattress was allegedly 1.5 inches (3.8 cm) too height.The bump on the patient's head was reported as an outcome of this event.An ambulance was called but after the patient's assessment, a transfer to a hospital was deemed unnecessary.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15690709
• MDR Text Key: 305993974
• Report Number: 3005619970-2022-00024
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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 Sex: Male