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

Model Number	633026CA
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The nurse reported that the patient's pressure injury stage iv worsened and doubled in size (from l: 3.92cm x w:1.95 cm to l:6.39cm x w: 9.11 cm).Allegedly, the tubing running from the pump into the mattress was pinched which led to low air flow.The pump did alarm informing staff of the issue.
Additional Manufacturer Narrative
Follow-up report was submitted to add udi.

• 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: 17008596
• Report Number: 1419652-2023-00035
• Device Sequence Number: 15326668
• Product Code: FNM
• UDI-Device Identifier: 05059441149927
• UDI-Public: (01)05059441149927(11)220217
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023
• Report Date (Section F): 06/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 633026CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/21/2023
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/21/2023