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

Model Number 633026CA

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event 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.

Manufacturer Narrative

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 airflow.The mattress was sliding down pinching the hose.The pump did alarm informing staff of the issue.In the course of the investigation the hypothesis was made, that the mattress (size 34x78x7 in) might have not been compatible with the non-arjo bed frame (size 36x80 in).As a result, the mattress placed on a non-arjo bed frame slid down and therefore pinched the tubeset.The velaris instruction for use (ifu, 04.Aav.00en_02) informs that ¿ the clinical or caregiver should assess the needs and determine which mattress and bed frame to use.See the bed frame ifu for compatible mattress size.¿ the system triggered an alarm informing staff of the issue.As per the design, if the mattress fails to achieve the target pressure, the low pressure light turn on and an alarm sounds.However, the patient was left of the allegedly faulty mattress for up to 24 hours until the issue was resolved.According to ifu ¿the hybrid mattress system is indicated for the prevention and management of pressure injuries.It should be used as part of an individualized, comprehensive pressure injury protocol.This includes: repositioning, nutritional support and skin care (¿)¿ the hybrid mattress system represents one aspect of a pressure injury management protocol.All other aspects of care should be considered by the healthcare professionals.If existing wounds do not improve, or the patinet's condition changes the overall therapy regimen should be reviewed by the healthcare professional." sum up, lack of active therapy due to kinked mattress tubeset itself is not likely to lead to pressure injury development.Pressure injuries are complex and are a result of many factors including: advanced age, immobility, co-morbidities, microclimate, incontinence and lack of being turned or repositioned frequently enough.A support surface is one aspect that should be considered in regards to pressure injuries management regime.In the analyzed case, the patient had the pre-existing pressure injury stage iv.The arjo mattress was used while the patient condition worsened, therefore it played role in the event.The involved mattress did not work correctly due to pinched tube however the issue was recognized by the system which triggered a warning and informed the staff of the issue.We decided to report this incident to the competent authority solely due to reported patient's outcome.The kinked air tube itself is not likely to lead to injury.H3 other text : device in use.

Manufacturer Narrative

Based on the information collected at this time, the involved patient was deemed high-risk and had pre-existing stage 4 pressure injury.The patient was put on the velaris in active mode.When the patient was using the mattress, the low-pressure alarm on the velaris pump sounded and the patient was therefore left on a reactive surface for up to 24 hours before this was rectified.The patient's pressure injury worsened and doubled in size.A week after fixing the mattress the wound was l: 3.22 cm x w: 2.51cm.Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Process of gathering and analyzing information is still ongoing.So far no more information has been provided by the customer.

• 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: 17008597
• MDR Text Key: 315998646
• Report Number: 3007420694-2023-00110
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05059441149927
• UDI-Public: (01)05059441149927(11)220217
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 633026CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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): Required Intervention
• Patient Weight: 58 KG