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

Model Number 636002DE

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial information provided to arjo, there was a patient with wound healing problems or skin injury while using auralis mattress.Arjo representative followed up with the customer and was able to establish that over night the compressor got amber light, mattress fully filled hard, and it was not possible to change pressure settings.The staff was not able to set the auralis back to alternating therapy mode.The pump was taken out of use and returned for investigation.As per the information provided the patient sustained stage 3-4 sacral decubitus, which was assessed by arjo clinical specialist as a serious injury.The results of evaluation are not known at the time of submission of this report.

Manufacturer Narrative

According to the initial information provided by the customer, there was a patient with wound healing problems or skin injury while using the auralis mattress.Arjo representative followed up with the customer and was able to establish that overnight the compressor got amber light, the mattress was filled hard, and it was not possible to change pump settings.The customer suggested that the pump was in the ¿autofirm¿ mode.The staff was not able to set the auralis back to alternating therapy mode.The pump was taken out of use and returned for investigation.As per the information provided the patient sustained stage 3-4 sacral decubitus, which was assessed by arjo clinical specialist as a serious injury.After the event, the device was inspected by an arjo representative.The device evaluation showed that the pump and matters did not reveal any technician failure, the technician noticed, however, that the pump was in battery mode.The battery mode is activated in case of power failure.Also when there is less than 15 minutes of battery life left, the audible alarm is activated automatically.When the battery is low the mattress is set automatically to the cpl (constant lower pressure) mode and alternating therapy is no longer provided.The clp (constant lower pressure) mode maintains a constant lower pressure in all the mattress cells.The customer might sense that all mattress cells had equal air distribution and therefore believed that the mattress was hard or on autofirm mode.It is also suspected that, because of low battery, the caregiver could not be able to adjust the mattress setting to alternating therapy.The instruction for use for auralis 04.Ai.00en_03 includes the information and graphical explanation regarding low battery indicator: low battery indicator- the single (top) indicator is shown and an audible alarm sound when there is a minimum of 1-hour battery life left.The alarm can be muted.When there is less than 15 minutes of battery life left, the auralis pump enters the reactive clp mode.At this point, the audible alarm cannot be muted.¿ moreover, the instruction for use for auralis contains the section ¿troubleshooting and alarms¿ which guides the caregiver on how to resolve the problems with the device.The section contains information that when the battery is low, the caregiver should charge the battery by using the main power supply to run the auralis pump.The mattress did not show malfunction when it was inspected after the event, but it is suspected, that the mattress could have entered into the low battery mode during the event.It is unknown why the patient developed pressure injuries.This system is equipped with audible and visual alarms to alert caregivers in case the system enters in alarm condition.The instruction for use for auralis states that: ¿the system represents one aspect of a pressure injury (pressure ulcer) management protocol, all other aspects of care should be considered by the prescribing clinician.If existing wounds do not improve, or the patient¿s condition changes overall therapy regimen should be reviewed by the prescribing clinician.The system is indicated for the prevention and/or management of all categories of pressure injuries (pressure ulcer) when combined with an individualised, comprehensive pressure ulcer protocol; for example repositioning, nutritional support, skin care.¿ based on the facts and information provided to the complaint, the auralis pump might show a low battery indication, as the customer stated that the compressor showed amber light at the time when the event occur.Also, the device evaluation showed that the system was in the low battery mode.The battery mode might have been activated due to power failure at customer facility.The discharged battery did not lead to the reported pressure injury 3-4 stage injury, since there are multiple factors that might have led to the pressure injury.It has been established that the auralis system (mattress and pump) were being used for patient treatment.There was no device malfunction found, the device did not fail to meet its specification.We report this event to the competent authority, solely, due to the allegation of serious injury sustained by the patient while using the arjo device.

Manufacturer Narrative

Currently all gathered information is analyzed.More information will be provided upon investigation conclusion.

• Brand Name: AURALIS PUMP
• 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: 15585615
• MDR Text Key: 301556534
• Report Number: 3005619970-2022-00021
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636002DE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Date Device Manufactured: 05/10/2021
• 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): Required Intervention
• Patient Sex: Male
• Patient Weight: 60 KG