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

Model Number 47129

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The results will be provided in final report.

Event Description

Following the information provided the maxxair ets mattress turning function activated unintentionally without being initiated on the pump control panel by a user.At the time of the event the patient was on the mattress.No injury was sustained.It is unknown if at that time the bed side rails were raised or not.The system was swapped out and inspected.No fault was found.

Manufacturer Narrative

The arjo representative visited the customer facility within one hour of receiving the service call.Although the blower was in static mode and worked correctly, the device was swapped out and checked in the arjo service center.The claimed issue was not duplicated.No fault was found.Later, in the course of investigation we found out that the nurse shift manager denied that the unintended movement occurred.The statement initially provided by the customer appeared to be erroneous.In the initial statement, the customer claimed unintended activation turning function.According to the product instruction for use (ifu 310115-ah rev.4), the turning function can be activated by selecting turn type and duration by using the buttons located on the front panel.Moreover, ifu warns ¿prior to engaging turn feature, ensure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position".In summary, the complaint was initially assessed as reportable due to the information indicating that the mattress turning function activated unintentionally.In the course of the investigation, it appeared to be erroneous.The system was in use by the patient at that time.No injury occurred.After receiving additional information clarifying that the reported event did not occur, the complaint is deemed not reportable to competent authority.The arjo device met its specification as no fault was found.

Event Description

Arjo received a complaint on maxxair ets mattress replacement system (mrs).The system is equipped with the turning function.It allows for gentle tilting the patient to the left or right and due to that provides pressure relief.The customer reported that the mattress turning function activated unintentionally without being initiated on the pump control panel by a user.At the time of the event the patient was on the mattress.No injury was sustained.The system was swapped out and inspected.No fault was found.In the course of investigation we found out that the nurse shift manager denied that the issue even happened.

• 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: 19179168
• MDR Text Key: 341006650
• Report Number: 3007420694-2024-00113
• 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: 05/24/2024

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: 03/28/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2024
• 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): Other