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

Model Number 630009AU

Device Problem Electrical Shorting (2926)

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

Event Date 09/09/2023

Event Type  malfunction  

Manufacturer Narrative

Investigaition completion is ongoing.A supplemental report will be submitted when investigation is completed.

Event Description

Arjo became aware of the event involving the auto logic pump.The pump power cord was damaged when the customer¿s staff was closing the bed¿s side rails.The staff did not notice the cuts on the cable and tried to reset the circuit breaker few times.The short circuit occurred and the burning marks on the damage power cord were observed.The pump was in use by the patient when the event occurred.No injury was reported.It was reported that the cable management system was not used.The involved device was swapped out.

Manufacturer Narrative

The technician noticed that the cable was not positioned according to the instruction for use.The cable management flaps were not used.According to the auto logic instruction for use (b)(4), arjo recommends to ¿make sure that the mains power cable (.) are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.¿ sum up, the power cord was damaged by the bed¿s side rails, most likely because the cable management flaps were not used the power cord was found to be damaged and from that perspective, the device did not meet performance specifications.The device played a role during this event as it was used by the 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17867346
• MDR Text Key: 324875894
• Report Number: 3005619970-2023-00024
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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