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

Model Number	M8259978
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation to establish the root cause of the event is ongoing.Results will be provided in the final report.Udi number (b)(4).The device is distributed outside the us and no gudid information exists.
Event or Problem Description
Arjo became aware of the event involving therakair visio pump.The customer informed that the power cord was damaged and the huge spark was observed.The arjo service technician inspected the device and found that the cable was cut and the internal wires were exposed.The photographic evidence provided confirms malfunction and shows burning marks on the cable.The faulty part was replaced.The mattress was used for patient treatment when the malfunction occurred.No injury was claimed.
Additional Manufacturer Narrative
We were informed that the power cable was run over by a bed frame.The instruction for use (340750-ah rev f 06/2019) for therakair visio mattress replacement system instructs: "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 exact root cause of the malfunction was decided to be unintentional user error.The power cable of the pump was damaged; therefore, the arjo device did not meet the specification.The complaint was assessed as reportable due to the allegation that a spark was coming from the damaged power cord of the pump.The pump was in use by the patient when the problem occurred.No injury was sustained.Udi number: (b)(4).The device is distributed outside the us and no gudid information exists.

• Brand Name: THERAKAIR VISIO
• Common Device Name: 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: 21705370
• Report Number: 3005619970-2025-00009
• Device Sequence Number: 17314099
• Product Code: FNM
• UDI-Device Identifier: 05055982784139
• UDI-Public: (01)05055982784139(11)231023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: M8259978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown