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

Model Number 630EUR

Device Problem Increase in Pressure (1491)

Patient Problem Pressure Sores (2326)

Event Date 05/17/2022

Event Type  malfunction  

Event Description

The autofirm button located on the membrane label located on the front of the auto logic pump was activating itself continuously.The customer claimed that due to this malfunction, a patient sustained a pressure injury.At this time the stage of pressure injury is unknown.It is also unknown if any medical intervention was needed.

Manufacturer Narrative

Based on currently available information, the autofirm button was activating itself continuously because was defective.Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

The autofirm mode was activating itself continuously.The customer alleged that that due to this malfunction, a patient sustained a pressure injury (stage was not provided).It is unknown if any medical intervention was needed.

Manufacturer Narrative

The autofirm mode was activating itself continuously.The customer alleged that that due to this malfunction, a patient sustained a pressure injury (stage was not provided).It is unknown if any medical intervention was needed.The autofirm function creates a temporary firm surface to allow nursing procedures to be performed.To activate this mode, the autofirm button should be held for 2 seconds.The comfort control led's will illuminate in sequence while the mattress is being inflated to autofirm pressures.Once the mattress has reached pressure all comfort control leds will remain illuminated, and the pump will beep three times.The reactive (clp - constant lower pressure) led will also illuminate.Autofirm lasts 15 minutes, after which the pump will default back to the previous setting.When the pump is in autofirm mode the clp and comfort control leds are illuminated.The technician found that the clp led indicator was not illuminating and that the autofirm button on the membrane label was defective.The problem was solved by replacement of the membrane label.The claimed pump was manufactured in 2009 (it was 13 years old at time of the event).The last preventive maintenance inspection was conducted by arjo, on 28 jun 2021 and no defect with membrane was identified.It is unknown how long the autofirm function turned on itself, there was no allegation from the patient on discomfort.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.According to instruction for use (630933en_1), the autologic system is indicated for the prevention and/or management of all categories of 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 care needs.These systems represent one aspect of a pressure ulcer management protocol; all other aspects of care should be reviewed by the prescribing clinician.If existing wounds do not improve or the patient¿s condition changes the overall therapy regime should be reviewed by the prescribing clinician.¿ in summary, the device was is use when the claimed issue occurred.The pump was malfunctioned as the autofirm mode was activating itself and therefore the device did not meet specification.However, the defective membrane causing that the autofirm mode was activating is not considered safety related.When this mode is activated the pump will flush with led¿s and the beeping sound is heard.Review of complaints from the last 3 years has revealed that this failure did not result in a serious injury in the past, therefore it is considered that it will not result in a serious injury in the future.This complaint has been reported to competent authorities with a caution approach, solely, due to an allegation of an 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14630032
• MDR Text Key: 293612925
• Report Number: 3005619970-2022-00009
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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: 630EUR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2009
• 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