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

Model Number 630001

Device Problem Sparking (2595)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Arjo was informed by a customer representative about an issue involving an auto logic system.The device malfunction allegedly resulted in ¿a bit of fire¿.It is unknown if there was any patient involved.No injury was reported.

Manufacturer Narrative

The customer facility was visited by an arjo representative but no additional information were provided.No signs of burning marks were found during the pump inspection.It was only found that the pump power cord was mechanically damaged.Based on condition of the cable, it can be stated that it was stuck between the beds moving parts what may result in occurring of sparks.This would suggest that the cable management flaps were not used.The claimed device was part of rental fleet.It was delivered to the customer and installed by the arjo technician on a bed.The technician stated that he used cable management flaps to secure the power cable.At the moment of installation, the bed was located in a side storeroom.It is suspected that the system was moved to a different bed and cable management flaps were not used.Lack of use the cable management flaps may contribute to the power cord damaged between the beds moving parts.According to the instruction for use (630933en), arjo recommends to ¿make sure that the mains power cable (.) are 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, as described in this manual.¿ the power cord was found to be damaged and from that perspective, the device did not meet performance specification.It is unknown if there was any patient involved when the pump malfunction occurred.No injury or other medical consequences were reported.The complaint was assessed as reportable due to indication about occurring the sparks from the power cord cable with damaged insulation.

• 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: 14191576
• MDR Text Key: 293613056
• Report Number: 3005619970-2022-00008
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784238
• UDI-Public: (01)05055982784238(11)180522
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2022

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: 630001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• 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