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

Model Number 413412

Device Problem Sparking (2595)

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

Event Date 03/27/2024

Event Type  malfunction  

Event Description

Following the information gathered, the damaged power cord cable and sparks coming from the power cord were claimed by a customer.It was found that by arjo technician that the power cord cable was run over the bed frame and it could have caused the failure.The broken part was replaced.The mattress was in use for patient treatment when the malfunction occurred.No injury was claimed.

Manufacturer Narrative

The evaluation confirmed that the power cable was run over by a bed frame.As a result, the power cord became damaged and sparks were observed.The instructions for use (340750-ah rev f 06/2019) for therakair visio pump and mattress system indicates that: "the power cable should be positioned to avoid a tripping hazard and / or damage to the cable.Arjo recommends placing the cable under the bed frame and attaching it to a mains wall socket by the head of the bed.The system should never be operated with a worn or damaged power cable.Should the power cable be found to be worn or damaged, contact arjo or an arjo-authorized representative for a replacement." the evaluation confirmed that the power cable was run over by a bed frame.As a result, the power cord became damaged and sparks were observed.Arjo device failed to meet its performance specification since sparks were coming from the damaged power cord.The device was used for a patient treatment when the malfunction was noticed.The complaint was assessed as reportable due to the allegation that sparks were coming from the damaged power cord of the pump.No injury was sustained.

• Brand Name: THERAKAIR VISIO
• 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: 19179266
• MDR Text Key: 341792486
• Report Number: 3005619970-2024-00014
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 413412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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