MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number KA9PUMP-EU

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the device performed by an arjo representative revealed that both mattress and pump were in a good condition.No abnormalities were found within the mattress.The pump was confirmed to function normally.Based on the available information the most likely root cause of the reported patient fall is use error.The information provided indicate that the side rails were not used due to patient's mobility assessment, which could have contributed to the fall.The instructions for use for atmosair 9000a (416412 rev.2) includes the following information related to patient falls: "side rails and restraints - warning: use or non-use of restraints, including side rails, can be critical to patient's safety.Serious or fatal injury can result from non-use (potential patient falls) of side rails or other restraints." whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family.Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed." 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 device evaluation.This complaint is deemed reportable due to allegation of patient's fall from arjo device.

Event Description

Following the information provided the patient fell from the atmosair 9000a mattress.The patient was found by the customer's staff on the floor, wrapped in her duvet, on the right side of the bed.The bed exit alarm was set up and alerted nursing staff, when the patient fell to the floor.The patient sustained minor injury - skin tear on the left arm.At the time of event the competitor's bed was in use (stiegelmeyer bed).The side rails were not in use with this patient because her mobility class was assessed as b - (meaning: the resident/patient is partly capable of performing daily activities independently and the assistance she requires is not generally physically demanding for the caregiver).As per the interviewed nurse, nothing further is clear about how exactly the incident happened.

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14487210
• MDR Text Key: 300361737
• Report Number: 3007420694-2022-00076
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2022

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: Lay User/Patient
• Device Model Number: KA9PUMP-EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 45 KG