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

Model Number 630004PL

Device Problem Melted (1385)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

This allegation refers to the auto logic system.During the preventive annual maintenance the arjo service technician noticed melted mains lead plug.He checked electricity sockets in the rooms in which the pump was used and did not find any burning signs.The circumstances in which the plug was damaged are unknown.There is no indication that the pump was in use when the malfunction occurred.No injury was reported.The system was taken out of use.The inspection revealed that the pump was working for more than 1900 hours.Thus the compressor will be replaced as its lifetime passed.Moreover, the mattress air leakage from a tubeset was identified.

Manufacturer Narrative

The pump¿s inspection revealed no faults related to the electric components that could cause that the device temperature increased and it started to melt.Thus, the most probable root cause of the melted plug was the contact with external source of heat.The routine maintenance section of the auto logic instruction for use (ifu 630933en_02 dated on jun 2014) states: ¿check all electrical connections and power cord for signs of excessive wear or damage.¿ moreover, ¿if the pump has been subjected to abnormal treatment, (¿), the unit must be returned to an authorised service centre.¿ in the complaint at hand the customer was not aware of the problem.The melted plug was identified during the preventive annual maintenance.When inspected the pump, arjo service technician found that the device was working for more than 1900 hours.Thus the compressor will be replaced as its lifetime passed.Moreover, the air leakage from the mattress tubeset was identified.The revealed issues were not related to the melted plug and did not influence the investigation results.Sum up, the complaint was decided to be reportable due to the melted plug of the pump.It was damaged most likely by the contact with external source of heat because the pump¿s inspection revealed no faults related to the electric components that could cause that the device temperature increased and it started to melt.

Event Description

This allegation refers to the auto logic system.During the preventive annual maintenance the arjo service technician noticed melted mains lead plug.The circumstances in which the plug was damaged are unknown.The electricity sockets in the rooms in which the pump was used were checked.No burning signs were found.There was no indication that the pump was in use when the malfunction occurred.No injury was reported.The system was taken out of use.

• 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: 19048952
• MDR Text Key: 339892365
• Report Number: 3005619970-2024-00010
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/29/2024

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: Health Professional
• Device Model Number: 630004PL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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