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

Model Number 630EUR

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation is ongoing, no final conclusions are available at this time.

Event Description

On (b)(6) 2021, a malfunction of auto logic pump was reported to arjo by the customer representative.After receiving the communication about the malfunction occurrence, an arjo representative was dispatched to pick up the faulty pump ((b)(4)) and deliver new device ((b)(4)).At that time there was no indication that any injury occurred.On (b)(6) 2021, arjo received an adverse incident report ((b)(6)) from (b)(6) suggesting that a patient developed dti to left foot due to malfunction of auto logic system.According to information provided by the initial reporter, the auto logic mattress deflated overnight and when replaced second mattress also deflated.The patient was transferred on other device (atmosair mattress) until replacement was available.In the report submitted by the customer, (probably due to error) incorrect serial number of the involved pump was provided.The device involved in the reported incident was (b)(4), not as it was mentioned by the customer (b)(4).It was also clarified that the one mattress deflated, not two at it was stated by the customer.The second system is still in use in the customer facility as it was not malfunctioned.

Manufacturer Narrative

An additional evaluation of the involved device at manufacturing site is needed to establish root cause of the pump malfunction.Pump return to the manufacturer was initiated therefore no final conclusions are available at this time.

Manufacturer Narrative

On 10 feb 2021, a malfunction of auto logic pump was reported to arjo by the customer representative.After receiving the communication about the malfunction occurrence, an arjo representative was dispatched to pick up the faulty pump ((b)(6)) and deliver new device ((b)(6)).At that time there was no indication that any injury occurred.On 17 feb 2021, arjo received an adverse incident report ((b)(4)) from mhra suggesting that a patient developed dti to left foot due to malfunction of auto logic system.According to information provided by the initial reporter, the auto logic mattress deflated overnight.It was replaced but the second mattress, allegedly, was also deflated.The patient was transferred on another device (atmosair mattress) until replacement was available.In the report submitted by the customer, (probably due to error) incorrect serial number of the involved pump was provided.The device¿s serial number involved in the reported incident was (b)(6), not as it was mentioned by the customer (b)(6).It was also clarified that one mattress deflated, not two at it was stated by the customer.The second system is still in use in the customer facility as it was not malfunctioned.An evaluation of the pump performed at arjo service centre did not reveal a clear root cause of the reported pump malfunction.At time of first test, the pump worked without any issues for 20 minutes.At time of second test, a noise could be heard coming from one of the capacitors (pcb component).It was decided to return the pump for additional evaluation at manufacturing site.The additional test revealed that the returned device did not turn on.It was caused by the defective power cord socket located on the pcb.It was broken and in the result, the power was not delivered to the pump.It is unknown in which circumstances the socket was damaged.We are not able to establish if the above issue contributed to alleged mattress malfunction.As per pump design, the red power fail indicator located on the pump casing illuminates when a mains power failure is detected and no battery backup is available.An audible alarm sounds until power is resumed.No issue with the alarm was observed, it worked correctly.According to instruction for use (630933en_04) ¿the auto logic systems are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.Selection should be based upon a holistic assessment of the patient¿s individual care needs.¿ 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.A support surface is only one of many interventions that are needed in order to prevent pressure injuries.Based on the above, it has been concluded that the individual care needs were not met by the facility staff leading to patient¿s development of the pressure injury.In conclusion, the arjo auto logic system (both mattress and pump) was used while the patient developed pressure injuries, therefore it played role in the event.The involved system was malfunctioned therefore it did not meet its specification.We decided to report this incident to the competent authority due to reported outcome, the patient developed the pressure injuries (dti).

• 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: 11480642
• MDR Text Key: 250643087
• Report Number: 3005619970-2021-00004
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)160727
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630EUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention