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

Model Number 630009AU

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The circumstances in which the power cable was damaged are unknown.However, we were informed that the cable was not positioned in the mattress cable management system.According to the auto logic instruction for use (630933en_04), it is recommended to ¿make sure that the mains power cable is clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress¿.The customer staff was aware of the damaged power cable and remove the device from use.The pump was repaired by the power cable replacement.No more faults were found.Sum up, the complaint was decided to be reportable due to the burning marks on the cut plug of the pump.The power cord was damaged most likely by the bed¿s moving parts because the cable management flaps were not used.The damage of the power cable was a contributing factor to the appearance of burning marks.The power cord was found to be damaged and from that perspective, the device did not meet performance specifications.The device played a role during this event as it was used by the patient.No injury or other medical consequences were reported.The complaint was assessed as reportable due to the burning marks on the damaged power cord.

Event Description

Arjo became aware of the event involving auto logic pump.The customer alleged that the faulty plug short circuited and blew out.The photos provided by the customer show burning marks on the cut plug.The pump was in use by the patient when the issue was observed.No injury was reported.The pump was taken out of use and repaired by the power cable replacement.

• 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: 18984953
• MDR Text Key: 338659395
• Report Number: 3005619970-2024-00006
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2016
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG