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

Model Number 47129

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided the patient was discovered by the nurse laying on the floor of the room.As per the information provided the mattress was "overinflated" on one side and the patient fell out of the bed.The bed side rails were locked in raised position.The patient was transferred to a house frame.The customer stated that the patient might have sustained a head injury, however this information was not confirmed.Further attempts to contact the customer and obtain additional details about the outcome were unsuccessful.The patient was scheduled for discharge 3 days after the event.There is no indication of serious injury sustained.

Event Description

Following the information provided, the patient fell from the maxxair ets mattress placed on the citadel plus bed.No serious injury was sustained.An arjo service consultant received an allegation of the mattress over-inflation on one side of the bed.The charge nurse stated that the patient was found lying on the floor with a possible head injury, after the alleged fall over the left side rail.Allegedly, the side rails were in upright position and the backrest section was set to 30 degrees at that time.The bed was taken out of use.During gathering information in the carried-out investigation, the customer did not respond to the questions regarding the confirmation of the patient¿s injury and the possible outcome of the injury.

Manufacturer Narrative

No malfunction was found during the bed and mattress evaluation at the customer¿s site.Furthermore, upon assets returning to the service center an in depth quality functional check was completed by the field service technician with no faults found.The cause of the fall cannot be established due to the patient being found by a caregiver on the floor, and allegedly all side rails were in the up position at the time of the incident.Furthermore, the device (mattress and bed frame) evaluation did not reveal any malfunction and it was working per specifications, therefore it was not possible to confirm the reported issue - mattress overinflation to one side.The fall is unlikely to occur when the side rails are in full upright position as indicated by the maxxair ets instruction for use (310115-ah): ¿it is recommended that side rails (if used) be locked in the full upright position when the patient is unattended.Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency.¿; ¿warning: use or non-use of restraints, including side rails, can be critical to patient safety.Serious or fatal injury can result from (¿) non-use (potential patient falls) of side rails or other restraints.¿ additionally, ifu instructs to: ¿consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk.¿ based on the available information it could not be concluded what caused the patient fall in the complained scenario.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.

• 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: 15759324
• MDR Text Key: 307730664
• Report Number: 3007420694-2022-00182
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• 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