MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. VELARIS MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	633028EN
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sustained the dtpi (deep tissue pressure injury) on the left buttock/coccyx area when using the velaris mattress.The mattress was noted to be sucked in the middle and the middle cell was noted to be deflated.Connecting the mattress to the pump did not change the mattress status.
Additional Manufacturer Narrative
The investigation is ongoing.Additional information will be provided upon investigation conclusion.
Additional Manufacturer Narrative
The investigation is ongoing.Additional information will be provided upon investigation's conclusion.The initial device evaluation revealed that the mattress cells had slid forward, the snaps from the cells were undone and the hoses were unplugged.It is unknown how and when these failures occured.There is a need to conduct a deeper analysis related to the reported problem.
Additional Manufacturer Narrative
An analysis of the gathered data on the reported issue is still ongoing.A review of historical data would be needed.
Additional Manufacturer Narrative
The investigation is ongoing.More time is needed to verify the available information.
Additional Manufacturer Narrative
It was reported that the patient sustained the dtpi (deep tissue pressure injury) on the left buttock/coccyx area when using the velaris mattress.The customer alledged that the mattress was dipping in the middle.The mattress was taken out of use.The mattress returned to the arjo service center where it was inspected.The inspection showed uneven surface, cell out of possition, snaps not attached to the cells, tube disconnection.It is unknown when the mentioned issues occured, at the hospital, during therapy, or while the mattress was being moved to the service center.The velaris mattress is a hybrid mattress build of foam, which could slightly indent when a patient is laying on the foam.The risk assessment related to the failures that were found during mattress evaluation, indicates that the serious injury is unlikely.Product instruction for use indicates that the hybrid mattress system is indicated for the prevention and management of pressure injuries.It should be used as part of an individualised, comprehensive pressure injury protocol.This typically includes: repositioning, nutritional support and skin care.The surface should be selected based on full assessment of the patient needs.The hybrid mattress system represents one aspect of a pressure injury management protocol.All other aspects of care should be considered by the healthcare professional.If existing wounds do not improve, or the patient¿s condition changes the overall therapy regimen should be reviewed by the healthcare professional.It is unknown why and how the pressure ulcer developed.It is worth noting that the prevention and management of pressure ulcers is a holistic patient care activity.Nursing management includes a 24-hour individualized repositioning regime, early mobilization, good nutrition, management of incontinence, and restricted time spent seated.Taking the above into account, the cause of the development of a serious injury was not established.The mattress failed to meet its specification since some faults were detected.Connection between the mattress and the patient's wound was not established.The mattress was used for the patient treatment when injuries were noticed and therefore played a role in the event.

• Brand Name: VELARIS MATTRESS
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 20301014
• Report Number: 3007420694-2024-00244
• Device Sequence Number: 15401684
• Product Code: FNM
• UDI-Device Identifier: 05059441149941
• UDI-Public: (01)05059441149941(11)220114
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 633028EN
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/23/2024; 11/22/2024; 12/20/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 92 KG