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

Model Number 630EUR

Device Problem Electrical Shorting (2926)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

At the time of an auto logic pump inspection, an arjo technician detected signs of burning marks on the damaged pump power cord.There was no patient involvement.No injury was reported.

Manufacturer Narrative

At the time of an auto logic pump inspection, an arjo technician detected signs of burning marks on the damaged pump power cord.There was no patient involvement.No injury was reported.The customer asked for a repair of the pump without providing any details.It was only indicated that the pump did not work.The device was evaluated by an arjo technician.The photographic evidence provided confirmed detected malfunction.The power cord was mechanically damaged, on the broken insulation there were visible signs of burning marks.The involved device is the property of the customer.It was unknown who installed the device and whether the cable management system (in which the power cable can be positioned in order to secure the cable) was used.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.¿ based on the collected information and post-market surveillance data the most likely cause of the damage could have been the incorrectly secured pump power cable.The cable may have been trapped by the bed¿s moving mechanism.The circumstances of the malfunction occurrence remain unknown and the customer was not aware of the detected damage.The power cord was damaged and from that perspective, the device did not meet performance specifications.There was no patient involvement.The complaint was assessed as reportable due to signs of burning marks on the damaged power cord.

• 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: 15922232
• MDR Text Key: 307985392
• Report Number: 3005619970-2022-00030
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)210410
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630EUR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2021
• 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