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
Additional Manufacturer Narrative
The investigation is ongoing.
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.

• 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
• MDR Report Key: 20301006
• Report Number: 1419652-2024-00059
• Device Sequence Number: 15401563
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2024
• Report Date (Section F): 09/25/2024

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Date Report Sent to FDA: 09/25/2024