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

Model Number UNKNOWN

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

On 7th of mar 2022, arjo received a copy of the customer report (ref.(b)(4)) with allegation about an auto logic (variant 200) malfunction which occurred at time of use the system by a patient.When the patient was turned during the morning hygiene, the staff observed that the mattress was ¿extra inflated¿.After few minutes, the mattress allegedly deflated and the patient¿s was laying on the bed¿s metal slats.No alarm was heard by the customer staff.The patient suffered a back pressure injury (non-serious) with a blister causing pain and discomfort.

Manufacturer Narrative

Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Process of collecting information is still ongoing and no final conclusions are available.We are trying to contact with the customer to perform the device evaluation and establish root cause.So far, no additional information has been provided to arjo.

Manufacturer Narrative

On 7th of mar 2022, arjo received a copy of the customer report (ref.(b)(4)) with allegation about an auto logic (variant 200) malfunction which occurred at time of use the system by a patient.It was reported that on (b)(6) 2022, when the patient was turned during the morning hygiene, the staff observed that the mattress was ¿extra inflated¿.After few minutes, the mattress allegedly deflated and the patient¿s was laying on the bed¿s metal slats.No alarm was heard by the customer staff.The patient suffered a back pressure injury (non-serious) with a blister causing pain and discomfort.An arjo representative contacted with the customer.Based on additional information provided on 19th apr 2022, it was stated by the customer that the patient was transferred for a surgery at 2 p.M.On (b)(6) 2022 without any pressure injuries, the patient was circulatory unstable and received large doses of noradrenaline.The patient returned from the surgery at 5.15 p.M.To the intensive care unit.After the patient had been transferred from the anaesthesia, the nurse discovered that the mattress was without air.That time, the nurse observed that the patient developed the pressure injury and that the mattress was deflated.The customer representative speculated in the e-mail sent to arjo that either the mattress could deflate because the air hose was not disconnected from the pump during the patient¿s transport or that the power had not been reconnected to the pump in an operating room.When the mattress tubeset is disconnected from the auto logic pump, the mattress is put into transport mode.The air is kept in the mattress allowing to support the patient up to 12 hours.Transport mode allows to maintain a constant pressure within the mattress without the need to connect the mattress to the pump unit.Transport mode is a non-therapeutic feature offering a support for patients, for example for transfer.Transport mode can be also used in a power fail condition.According to instruction for use (630933en) ¿ if a power fail condition arises and no battery is connected, disconnect the tubeset from pump.This will put the mattress into transport mode.¿ the root cause of this event could not be confirmed as no inspection of the involved auto logic system was conducted (the serial numbers were not noted by the customer therefore we were not able to locate the devices).The circumstances in which the patient developed the injury are also unclear.Initially we were informed that occurred on (b)(6) 2022, later that after the patient transfer on surgery on (b)(6) 2022.Pressure injuries are complex and are a result of many factors including: advanced age, immobility, co-morbidities, microclimate, incontinence and lack of being turned or repositioned frequently enough.In summary, the auto logic system played a role during this event as it was used by the patient.The mattress was deflated therefore the device did not meet specification.Arjo decided to report this complaint in abundance of caution due to unclear information about the circumstances in which the event occurred and lack of access to the involved system.The mattress (included sub-mattress) was allegedly deflated and the low pressure alarm was not heard.The patient sustained a back pressure injury (non-serious) with a blister causing pain and discomfort.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13886303
• MDR Text Key: 289663641
• Report Number: 3005619970-2022-00005
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2022

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: Other
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/07/2022; 04/19/2022
• Supplement Dates FDA Received: 04/19/2022; 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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