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

Model Number 47129

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow-up report once available.

Event Description

Following the information provided the maxxair ets system was malfunctioning, contributing to difficulty with wound care.A tube inside the mattress would not stay connected causing air to leak out and the patient to lie lopsided (towards the affected side) on the bed.Lastly, because the device was malfunctioning and was not replaced, the nursing staff shut off the pump causing the patient to rest on a deflated mattress on top of a bed frame for approximately 2 days which they admit is the primary reason for the worsening condition of the wound.The patient had a hospital acquired pressure injury that did not occur as a result of the arjo device, however malfunctioning of the device likely contributed to worsening, or at least prevented improvement, of the wound.The injury that patient sustained was worsening of deep tissue injury that advanced to an unstageable (but likely stage iv) wound.The device was returned to arjo service for evaluation.

Manufacturer Narrative

The patient wounds worsened while using the mattress.The customer stated that the mattress was malfunctioning (inner air hose disconnected) and the delay in delivery of replacement mattress contributed to worsening of deep tissue injury that advanced to an untraceable (but likely stage 4) wound.However this was not the primary factor.The primary factor listed by the facility, was the unsafe use of mattress by nurses as they turned off the air supply unit (the pump) for an extended period of time (2 days).Another nurse discovered patient on a deflated mattress and placed waffle mattress under the patient.The tape was placed over the disconnected hose (as per the customer).A history of this device revealed that the device was delivered to the facility 14 november and the malfunction was discovered 11 days later, therefore it is unknown how the inner air hose became disconnected from the cell.The mattress deflation was a result of turning off the air supply unit (the pump).When the air supply unit is turned off, the air is not delivered to the mattress.If the maxxair ets air supply unit is turned on, it will blow the air continuously, it means that even if there is a leak, there will not be a complete mattress deflation.Therefore, the factor which contributed to the worsening of patient's injury is related to leaving the patient on a deflated mattress for 2 days.Product instruction for use (ifu, 310115-ah rev 3 ¿09/2019) includes the following safety information: "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." "general protocols ¿ follow all applicable safety rules and institution protocols concerning patient and caregiver safety." taking all the available information, it has been determined that the cause of the worsening of patient deep tissue injury to an untraceable (but likely stage 4) wound was related to not following safety protocols.The inner hose disconnection is not considered safety related.The device was used for a patient treatment when the worsening of patient wounds was discovered, the mattress had an inner hose disconnection and from this perspective it did not meet its specification, however the worsening of patient's wounds is related with leaving the patient on a deflated mattress, after the air supply unit was turned off.This complaint is deemed reportable following customer statement indicating a worsening of existing wounds, which have been deemed a serious injury.H3 other text : specific product not identify.

• 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: 16086310
• MDR Text Key: 306528056
• Report Number: 3007420694-2023-00003
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: 12/05/2022
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 265 KG