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

Model Number 47129

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available information it could not be concluded what caused the patient fall in the complained scenario.The device evaluation did not reveal any malfunction and it was working per specifications, therefore it was not possible to confirm the reported issue.The instruction for use for maxxair ets (310115-ah) includes the following information related to the turning feature of the device: ¿the turn assist feature slowly inflates the appropriate turning bladders to gently tilt the patient to the left or right.¿; ¿caution: prior to engaging turn feature, ensure that the bed frame has side rails and that all side rails are fully engaged in their full upright and locked position.¿ additionally the instruction for use for citadel plus bed (831.374-en) instructs to: ¿consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk.¿.In summary, it was impossible to determine the root cause of the patient fall.The device was used for patient treatment when the failure occurred.No malfunction was found on the device and it was working as intended.This complaint is deemed reportable due to the patient's fall from the device.

Event Description

Following the information provided the patient fell from the maxxair ets mattress placed on the citadel plus bed.No injury was sustained.The charge nurse claimed that the mattress became overinflated, which caused the patient to be ¿thrown over the left side rail¿, resulting in falling onto the floor.The turning feature, responsible for tilting the patient to the left or right during the performance of routine nursing care, was activated at the time of the incident.The appropriate turning bladders were inflated on the right side of the mattress and the patient fell on the left side of the bed, where the mattress was lower (left turning bladders were deflated).The side rails were raised at that time.An arjo representative performed an evaluation and provided a function test.No malfunction was found and the device was working as intended.

• 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: 15786781
• MDR Text Key: 307956123
• Report Number: 3007420694-2022-00184
• 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
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/14/2022
• 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): Other
• Patient Sex: Male
• Patient Weight: 154 KG