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

Model Number 630004DK

Device Problem Electrical Shorting (2926)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The technician who inspected the device and contacted the customer established the cable has been squeezed between the beds parts.It was positioned without the use of the cable management flaps.At this customer facility, the installation of the auto logic systems is done by the customer staff.The customer stated that they were fully aware of how to install the pump power cord, with the use of the mattress cable management system, but they never used them.The reminder to use the mattress cable management system has been already provided to the involved customer.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 investigation revealed that the lack of use the cable management flaps contributed to the power cord damaged between the beds parts.The power cord was found to be damaged and from that perspective, the device did not meet performance specifications.The device was in use by a 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

At the time of an auto logic pump inspection, an arjo technician detected signs of burning marks and a short circuit on the pump power cord.The device was returned to arjo because, allegedly, it did not turn on when it was in use.No injury occurred.

• 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: 15728132
• MDR Text Key: 306924674
• Report Number: 3005619970-2022-00026
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)190408
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630004DK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• 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