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

Model Number 633014

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

Power cord was damaged and sparked.The customer stated that the power cable got caught when they were moving the bed frame into upright position.An upright position may indicate that the caregivers were raising the backrest section.There was no injury.The patient was removed from the mattress.The involved pump was swapped out.The arjo service technician inspected the pump and confirmed the damage.Photographic evidences provided show a cable with internal exposed copper wires.

Manufacturer Narrative

The device was in use for about 1,5 months before the event happened and it is unknown how the power cable was handled.Product instruction for use (ifu) 04.Aav.00en_03 states: "position the power cable in the cable management loops on the left side of the mattress"."secure the cable using the six cable loops with locking clips.Fold down the zip flap over the power cable and loops".Product instruction for use also indicates that power cable should be inspected before every use or every week.Based on the analysis it can be assumed that the power cable might not have been securely positioned in the cable management loops and therefore caught by the bedframe mechanism when it moved.The service technician observed that the place of damage could indicate, that the power cable was hanging down between the locking clips and therefore got caught.The pump failed its specification because power cable became damaged, however it was damaged due to external factor - moving bed frame mechanism.The pump was used for treatment when the event happened and therefore played a role in the event.There was no injury.This event is reportable due to power cable damage causing sparks.

• Brand Name: VELARIS PUMP
• 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: 18571600
• MDR Text Key: 334751017
• Report Number: 3005619970-2024-00002
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05059441147770
• UDI-Public: (01)05059441147770(11)230425
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 633014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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