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

Model Number 633027EN

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem Pressure Sores (2326)

Event Date 06/02/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.When conclusion is available the final report will be provided.

Event Description

Arjo became aware of the event involving the atmosair velaris mattress.The customer reported the cell displacement causing uneven mattress surface.Patient sustained the stage iii pressure injury on his sacrum.The clinical specialist assessed the injury as serious.

• Brand Name: VELARIS MATTRESS
• Type of Device: 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: 17215387
• MDR Text Key: 317988653
• Report Number: 1419652-2023-00041
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 633027EN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2023
• Distributor Facility Aware Date: 06/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male