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

Model Number 47129

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 02/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the patient fell from the maxxair ets mattress that was placed on the citadel plus bed.The photographic evidence provided shows that it is likely that the turning mode was activated on the mattress pump, when the lower right bed side rail was not locked in the raised position.There is no indication of any injury sustained to date.

Manufacturer Narrative

Based on the available information the most likely root cause of the reported patient fall is use error.The evidence provided indicates that the bottom right side rail was left in an unlocked, lowered position when the turning mode was activated and the patient was sleeping unattended.The instructions for use 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 was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was performing as intended.No malfunction was found during the evaluation of both the mattress and the bed.This complaint is deemed reportable due to patient's fall from the device.

Event Description

Following the information provided the patient fell from the maxxair ets mattress that was placed on the citadel plus bed.As per the information provided both head-end side rails and one foot-end left side rail were locked in raised position.The customer's staff is unsure whether the foot-end right side rail was raised or not.The photographic evidence provided indicates that the side rail was lowered.The turning mode was activated on the pump.The mattress was turned to the right side, with the left turning bolster inflated.The patient was sleeping at the time of event and there was nobody accompanying her.The caregiver found the patient on the floor, lying face down.As a result of the fall the patient sustained facial contusion and laceration to the forehead.The patient was taken to emergency department and had a ct scan of the head performed.

• 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: 14013624
• MDR Text Key: 288597627
• Report Number: 3007420694-2022-00047
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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
• Date Manufacturer Received: 03/08/2022
• 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: Female
• Patient Weight: 136 KG