MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 47129

Device Problems Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.When the information is available and the investigation completed a follow-up report will be provided.

Event Description

Arjo became aware of the event involving the maxxair ets mattress installed on citadel plus bed frame.The customer reported that the mattress was dipping and not inflating properly.The patient developed stage 4 pressure injury to right buttock.The mattress was swapped out and inspected.No faults were found.

Manufacturer Narrative

Arjo was informed that the patient was admitted to the hospital on (b)(6) 2022 with serious pressure injury.The patient was assessed on admission as at high risk of pressure injury development.The prevention and treatment of pressure ulcers/injuries: clinical practice guideline states: ¿risk assessment is an essential component of clinical practice that aims to identify individuals who are susceptible to pressure injury development, in order to plan and implement care that addresses the individual¿s risks.Skin assessment is crucial in pressure injury prevention because skin status is a significant risk factor for pressure injury development¿.On (b)(6) 2023 the patient developed stage 4 pressure injury to right buttock.According to the maxxair ets instruction for use (ifu 310115-ah rev 3) "skin care ¿ monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients.Give extra attention to skin over any raised side bolster and to any other possible pressure points and locations where moisture or incontinence may occur or collect.Early intervention may be essential to preventing skin breakdown." the customer stated that their internal protocol concerning pressure injury treatment was followed.Moreover, when new pressure injury developed, the customer reacted according to the maxxair ets ifu and provided alternative therapy.The patient was placed on citadel c200 system and his condition improved.Ifu states that maxxair ets mattress is indicated for prevention and treatment of pressure ulcers.However, mattress represent one aspect of a pressure ulcer management strategy.The prevention and treatment of pressure ulcers/injuries: clinical practice guideline indicates ¿five areas of care (nutrition, repositioning and early mobilization, heel pressure injuries, support surfaces and device related pressure injuries) that are important in both prevention and treatment of pressure injuries.¿ although the customer reported that the mattress was malfunctioning, it was not confirmed by the system inspection.Thus, we concluded that the patient outcome was not related to the arjo product.The most probable root cause of the patient¿s outcome was the patient¿s susceptibility to the pressure injury development what is confirmed by the presence of pre-existing pressure injury and the assessment on admission to the hospital.To sum up, the involved device did not malfunctioned thus we concluded that the mattress itself has not caused the patient¿s pressure injury development.We believe that the most probable root cause of the patient¿s outcome was the fact that the patient was at high risk of pressure injury development.The customer followed the ifu and provided alternative therapy when the patient developed new pressure injury.The patient was placed on citadel c200 system and his condition improved.The device was used for a patient treatment when he developed serious pressure injury, therefore it played a role in the event.Although the customer stated that the mattress was malfunctioning, it was not confirmed by the device inspection.The complaint was assessed as reportable due to the customer statement indicating development of serious pressure injury.

Event Description

Arjo became aware of the event involving the maxxair ets system consisting of maxxair ets mattress and maxxair ets air supply installed on citadel plus bed frame.The customer reported that the mattress was dipping and not inflating properly.The patient developed stage 4 pressure injury to right buttock which joined pre-existing sacrum to left buttock stage 4 pressure injury.The system was swapped out and quality controlled.No faults were found.

• Brand Name: MAXXAIR ETS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18666676
• MDR Text Key: 334837298
• Report Number: 3007420694-2024-00040
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG