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

Model Number 630001

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 10/24/2021

Event Type  Injury  

Manufacturer Narrative

The allegedly faulty auto logic pump was excluded from use and picked up by arjo.The customer received other pump.The cause of the alleged mattress deflation has not been established yet, as the investigation is ongoing.

Event Description

Arjo became aware that a patient has developed combined masd (moisture-associated skin damage) and unstageable pressure ulcer to the right buttock at time of use an arjo auto logic system.The patient¿s family raised concerns with the mattress which was being allegedly flat in the middle.

Manufacturer Narrative

On 3rd of nov 2021, arjo was informed by a nhs representative that the patient who was using arjo auto logic system developed combined masd (moisture-associated skin damage) and unstageable pressure ulcer to the right buttock.The patient¿s family raised concerns that the reported injuries were allegedly a result of mattress deflation in the middle section that occurred on (b)(6) 2021.Arjo investigation revealed that the claimed auto logic system is part of arjo uk rental fleet and it was rented by the customer in (b)(6) 2020 (over 12 months before the mattress fault was reported).The system was ordered for a patient with high risk of pressure injury (21 on the walsall risk score).On (b)(6) 2021 an arjo service technician who attended the site to verify the service request related to mattress deflation, found that the patient was sitting on a chair, the mattress was already flat (cpr, which is used to enable a quick mattress deflation, had been activated).The involved pump was taken to the service center for further inspection and in return, the patient received another pump.The mattress remained in use as no defect was identified.Further inspection of the pump did not reveal a failure that could influence the alleged mattress deflation.Only noisy compressor was found.According to auto logic instruction for use (ifu 630933), ¿the auto logic systems are indicated for the prevention and/or management of all categories pressure ulcer, when combined with an individualized, 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.¿ the auto logic pumps are equipped with the following indicators: 1.Low pressure indicator which illuminates whenever the pump detects low pressure within mattress.An audible alarm sounds unless silenced by the device operator.The indicator will turn off when requested pressure level is reached.2.Power fail indicator illuminates when a mains power failure is detected.An audible alarm sounds until power is resumed.According to auto logic instruction for use (ifu 630933), ¿if a power fail condition arises (¿), disconnect the tubeset from the pump.This will put the mattress into transport mode.¿ 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.Moisture-associated skin damage is caused by prolonged exposure to various sources of moisture, including urine or stool, perspiration, wound exudate, mucus, saliva, and their contents.The arjo auto logic system was used while the patient developed serious injuries, therefore it played role in the event.The involved system was allegedly malfunctioned therefore it failed to meet its performance specification.The complaint was assessed as reportable due to indication about the serious injury.

• 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: 12826233
• MDR Text Key: 282385604
• Report Number: 3005619970-2021-00020
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784238
• UDI-Public: (01)05055982784238(11)170427
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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): Required Intervention