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

Model Number 636B02

Device Problem Deflation Problem (1149)

Patient Problem Ulcer (2274)

Event Date 11/29/2021

Event Type  Injury  

Event Description

Following the information the customer noticed that the air mattress was almost completely deflated.At that time the patient was on the mattress, who had a sacred bedsore, having tunnelled about 25 cm.The patient sustained back pain because of being placed on the deflated surface.As per the customer's technician, the mattress "had to be drilled/punctured".The customer stated that as a result of the deflation, the patient's sacral area wound condition worsened.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Following the information received, the customer noticed that the air mattress was almost completely deflated.The patient who was placed on the mattress had a pre-existing medical condition - a sacred bedsore, tunelled about 25 cm.The patient sustained back pain because of being placed on the deflated surface.The patient was placed on the deflated mattress for over a week.The customer stated that as a result of the deflation, the patient's sacral area wound condition worsened.

Manufacturer Narrative

The evaluation of the device revealed that the tubeset could not be appropriately sealed into the pump air outlet.The tubeset was being pulled out of the pump air outlet by user without pressing the disconnection button.As a result the tubeset locking function became damaged.The tubeset connection became unsealed, resulting in a low pressure alarm and mattress deflation.The instructions for use for auralis (04.Ai.00en rev.03) includes the following information in relation to the investigated event: - "if the mattress (.) is disconnected while in use, the low pressure indicator is shown after 30 seconds.When the indicator is shown, there is an audible alarm." - "if the pump detects that a mattress is no connected when the pump starts, the low pressure indicator is shown and there is a single warning tone." - "the connector is removed by pressing the two side buttons simultaneously." - "visually check the tube-set and connector"; "check that the tubing is not damaged and that there are no obvious cracks or breaks to the connector" - it is a maintenance activity required to perform by the caregiver before every use or every week (if for long term use).Arjo device failed to meet its performance specification since the tubeset was damaged.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to serious injury (worsening of a tunneled wounds on the patient¿s sacral area) sustained by the patient.

• Brand Name: AURALIS
• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13024466
• MDR Text Key: 282385587
• Report Number: 3005619970-2021-00023
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636B02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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: Female