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 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

The customer staff claimed that a pump power cord was damaged at the time of closing the bed¿s side rail.The exposed wires contacted the iron side rail which heated up and the customer staff observed smoke.The device was in use at that time.No injury was reported.

Manufacturer Narrative

The customer staff claimed that an auto logic pump power cord was damaged at the time of closing the bed¿s side rail.The exposed wires contacted the iron side rail which heated up and the customer staff observed smoke.The device was in use at that time.No injury was reported.The photographic evidence provided by the customer confirmed the claimed issue.The power cord was mechanically damaged, on the broken insulation were visible signs of burning marks.Based on additional information received from the customer, the pump was installed by the customer¿s staff.The cable has been squeezed at the time of closing the bed¿s side rail because the cable was not positioned with the use of the cable management flaps.The cable management flaps were not available on the involved mattress because they were ripped off due to an unknown reason.The mattress serial number was not provided, therefore the history of the device and how long it was used, could not be verified.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 cable was incorrectly secured, therefore it was trapped by the bed¿s moving mechanism.The power cord was 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.

• 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: 15666299
• MDR Text Key: 305992962
• Report Number: 3005619970-2022-00022
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)190409
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• 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