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 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up reports once the investigation is completed.

Event Description

Following the information provided the mattress turning function activated unintentionally without activating it on the pump control panel.The turning bladder did not fill up because the hose was not connected with the mattress turning bladder.At the time of the event the patient was on the mattress.No injury was sustained.The arjo technician replaced the device and evaluated the mattress.The malfunction was recreated at the service center and it was determined that the valve was defective.Replacement of the component allowed to resolve the issue.

Event Description

Following the information provided 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.It is unknown if at that time the bed side rails were raised or not.The turning bladder did not fill up.The arjo technician visited the customer and found that the hose was not connected to the mattress turning bladder.The technician replaced the device and evaluated the mattress.The malfunction was recreated at the service center and it was determined that the turning valve was defective.Replacement of the component allowed to resolve the issue, the correct functionality was confirmed.

Manufacturer Narrative

Based on the collected information the turning function was confirmed to become activated unintentionally due to faulty valve, which remained open, resulting in inflation of turning bladder even if other mattress inflation modes were activated.The root cause of the valve malfunction is unknown.The ifu for maxxair ets 310115-ah rev.3 includes the following information related to the turning functions of the device: - "turning: caution: 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".Arjo device failed to meet its performance specification since the turning valve was faulty.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to allegation of unintended activation of the turning function during therapy.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13513656
• MDR Text Key: 288623955
• Report Number: 3007420694-2022-00020
• 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
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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 Operator: Other
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 03/11/2022
• 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