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

Model Number 636002NL

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/29/2022

Event Type  malfunction  

Event Description

Arjo has been notified of an incident involving the auralis pump medical device.It was reported that during a resident transfer, the resident received an electric shock.The resident did not sustain any serious injury.A caregiver who inspected the pump observed that the electric wire of the device was damaged.After the event, the pump was inspected by an arjo representative who confirmed the reported malfunction.The equipment was sent to arjo service unit and the faulty power cord of the device has been replaced.

Manufacturer Narrative

Arjo has been notified of an incident involving the auralis pump medical device.It was reported that during a resident transfer, the resident received an electric shock.The resident did not sustain any serious injury.A caregiver who inspected the pump observed that the electric wire of the device was damaged.After the event, the pump was inspected by an arjo representative who confirmed the reported malfunction.The equipment was sent to arjo service unit and the faulty power cord of the device has been replaced.During a visit to the customer, the service technician was informed by one of the caregivers that the damage to the pump power cord was most likely caused by the part being trapped between the moving parts of the bed¿s side rails.The instructions for use for the auralis contains the following information: "the power cable must be positioned in the cable management on the left side of the auralis mattress (.)".Additionally, the "care and preventive maintenance schedule - caregiver obligations action/check" section of the document instructs the user to check the auralis pump operation regularly: "before every use or every week (if for long term use) - visually check all electrical connections and power cord".From the information received, it appears that, the bed on which the resident was placed at a time of the incident was not an arjo bed.Taking into account the above facts obtained during this investigation, it can be concluded that the cause of the electric shock suffered by the resident was the damage of the pump's power cord.The damage most likely occurred as a result of the power cord being trapped between the moving parts of the bed¿s side rails.To sum up, the auralis pump was a part of a system used for a resident treatment when the damaged power cord of the device led to the resident¿s electric shock and from that perspective the device did not meet its performance specifications.The complaint was deemed reportable due to allegation of an electric shock sustained by the resident during use of the device.No serious injury was sustained.

• Brand Name: AURALIS
• 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: 15860285
• MDR Text Key: 307995222
• Report Number: 3005619970-2022-00029
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05056341675242
• UDI-Public: (01)05056341675242(11)201216
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 636002NL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG