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  

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.

Manufacturer Narrative

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

Manufacturer Narrative

The customer reported that their mattress had a cell out of position.The patient who was using the mattress developed stage iii pressure ulcer.The customer staff felt that the cells within the mattress were not alternating properly, therefore removed firesheet to examine the cells.The cells were found out of position.While gathering additional information to this complaint, arjo was informed that the customer believed, that the technique used to remove the cells, could worsen the cell positions and that the mattress was not quarantined and was put back into circulation (into use).The mattress was not inspected as it could not be identified by the customer.The customer health professional also stated that the mattress is not to blame for the patient outcome.When the mattress cell displaced, the defect is visible and mattress would not be used by the individual.In the complaint at hand the information received was that the mattress went back into circulation.Therefore, it is believed unlikely that the mattress in question was defective in a way that would lead to a serious injury.Review of complaints showed that there was no serious injury in the past related to the cell displacement.The cells are placed into foam cavity, patient would not be sitted on a bare frame, even if the cell will move.The relationship between the mattress and the patient outcome was not found.Pressure injuries are complex, all aspects of pressure injury management protocol should be considered.This includes repositioning, nutritional support and skin care.As per the product instruction for use 04.Aav.00en_02 dated 10/2021 "if existing wounds do not improve, or the patient's condition changes the overall therapy regimen should be reviewed by the healthcare professional".The arjo mattress was used when the patient allegedly sustained a serious injury and therefore the product played a role in the event.The cells allegedly moved out of position and therefore mattress did not meet its specification, however since the mattress could not be inspected, the allegation could not be verified.Arjo believes that cell displacement issue is unlikely to result in any pressure injury in the future if it was to recur.This complaint was assessed as reportable, taking a conservative approach and to be transparent, following an allegation that the patient developed a stage iii pressure ulcer while on arjo mattress.The development of pressure injury was confirmed by the customer healthcare professional not related to arjo product.H3 other text : customer could no identify the product.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17215385
• MDR Text Key: 317985201
• Report Number: 3007420694-2023-00152
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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
• Date Manufacturer Received: 06/29/2023
• 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
• Patient Sex: Male