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  

Manufacturer Narrative

Investigation is ongoing.Once the investigation results are available a supplemental report will be submitted.H3 other text : mattress not tagged by the customer for evaluation.

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.

Manufacturer Narrative

The investigation is still ongoing towards the allegation.This patient had multiple comorbidities and passed away 12 days after was admitted to the hospital.It is unknown if the pressure injury caused or contributed to the patient's death as there is not enough information from the facility to make an assessment.

• 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
• 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: 19002133
• MDR Text Key: 338878111
• Report Number: 3007420694-2024-00086
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female