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

Device Problem Dent in Material (2526)

Patient Problem Tissue Breakdown (2681)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Customer reported a serious pressure injury to a patient who was on velaris mattress.The report indicates that patient was admitted to facility on (b)(6) and the same day the unstageable pressure injury on the patient's sacrum was noted.Patient¿s pressure injury deteriorated on (b)(6).Patient had multiple comorbidities and braden score was 11.The facility is reporting that they mattresses have a dip and/or the sensation is that they may be too hard.These are mattresses built of foam, which responds to the patient¿s weight and patient¿s are supported on this foam.The investigation into the alleged dip in the center of the mattress is ongoing.This report is fulfilled taking a conservative approach, following the serious injury reported.

• 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: 19002127
• MDR Text Key: 338877855
• Report Number: 1419652-2024-00028
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2024
• Distributor Facility Aware Date: 03/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female