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

Model Number PXB001DAR

Device Problem Device-Device Incompatibility (2919)

Patient Problems Bruise/Contusion (1754); Physical Entrapment (2327)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

Arjo became aware of an event involving an arjo auto logic system and non-arjo bed frame (sidhill solite bed).It was claimed by the customer that a patient was found trapped between the mattress and the side panel of the bed.As a consequence the patient sustained a bruising to neck.It was indicated that the measured gap between the mattress and the bed side panel was about 6 inches.It was indicated that the mattress was inspected by an engineer (not arjo employee) who repaired a pin hole in the mattress due to leak.The mattress had not alarmed.The patient's family gave an opinion that the pin hole in the mattress could cause the mattress to deflate enough to come away from the bed side making the space bigger.

Manufacturer Narrative

The investigation is in progress, the final conclusions to be provided in the final report.

Manufacturer Narrative

Based on the information gathered during the investigation, it was determined that the auto logic system was being used on a standard bed frame equipped with side rails (sidhill solite bed).The measured gap between the mattress and the side panel of the bed was about 6 inches (15 cm).Consequently, another new bed was requested.It was indicated that after the event the customers third party service provider replaced the torso cell in the mattress due to leak and the silencer bag due to a hole.The customer gave an opinion that the pin hole in the mattress could cause the mattress to deflate enough which could contribute to the entrapment.This hypothesis could not be verified as the auto logic inspection performed by an arjo representative after repair revealed that the mattress and the pump were in good working order.No faults were found.Nevertheless, based on product knowledge and post-market surveillance data, the puncture of one cell may have deflated only one cell, not the entire mattress.The silencer bag absorbs the vibration of the compressor, so it does not cause the mattress to deflate also.The auto logic instruction for use (630933) contains the following warnings and information for the device user: "it is the responsibility of the care giver to ensure that the user can use this product safely." "alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body (.) care should be exercised to prevent occurrence of gaps by compression or movement of the mattress.Death or serious injury may occur." additionally, the ifu provides the information regarding the dimentions for the mattress.Verification of the instruction for use (ifu) for the non-arjo bed involved (sidhill solite bed) revealed that the following warnings and information are included in this ifu: "before a patient uses the bed a risk assessment must be performed on a patient by patient basis.The risk assessment should include, but is not limited to: - entrapment (.)" "ensure that any mattresses used are of the correct size and type and have been fitted correctly (.) ¿ incorrect mattress specification could lead to an entrapment and / or falls hazard." "care must be taken when positioning and adjusting side rails to ensure that any spaces between the side rails, mattress or bed frame will not allow entrapment of the occupant¿s head or body.In addition, consideration should be given to the size and physiological condition of the occupant and an assessment undertaken to ensure that the spacing between the bars of the side rails are not wide enough to present a potential risk of entrapment and / or asphyxiation.All staff responsible are to be aware that increased vigilance is required when nursing patients in beds fitted with side rails." sidhil bed ifu includes also list of complatible mattress which can be used with this bed.Auto logic system is not included in this list.Please note that the user can refer to the guidelines for reducing the risk of entrapment by consulting the local competent authority or government agency for medical device safety for specific local guidelines.Arjo devices (mattress and pump) were used for patient treatment when the event occurred and from that perspective played a role in the event.The customer claimed that the auto logic system had failed.However, this could not be confirmed as the system had been repaired by a third-party service provider prior to arjo's inspection.The complaint decided to be reportable due to patient entrapment reported.Minor injury was sustained as consequence.

• 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: 17009522
• MDR Text Key: 316001861
• Report Number: 3005619970-2023-00011
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• 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