MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. FIRST STEP CIRRUS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

The investigation results are pending completion.Once completed the supplemental report will be submitted.Unknown serial number therefore product not identified.

Event Description

The customer reported a patent fall from the first step cirrus mattress.The fall was not witnessed.It was speculated by the customer that the resident might sit up to adjust pump hoses and fell.Additional information was that the resident might have broken fibula bone and that the surgery was likely.The first step cirrus mattress overlay was placed onto the standard non-arjo mattress, creating the overall high of the surface at approximately 12'' (5¿ overlay + 7¿ mattress).This put the resident above the height of the bed side rails.It is unknown what type of bed is used, only that it was non-arjo ¿standard hospital bed¿.The customer correction included switching from their current mattress to the smaller mattress pad, which will be used with the first step cirrus.

Manufacturer Narrative

Correction to d3.The first step cirrus mattress overlay was placed onto the standard non-arjo mattress, creating the overall high of the surface at approximately 12''.This put the resident above the height of the bed side rails.Product instruction for use states: "bed height - to minimize the risk of falls or injury the bed should always be in the lowest position when the patient in unattended" "when selecting a mattress and overlay combination or mrs, ensure the distance between top of side rails (if used) and top of mattress (without compression) is at least 8.66 in (220 cm) to help prevent inadvertent bed exit or falls.Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk." the customer stated additionally that the therapy control unit did not have o-ring, causing the mattress to deflate.This however will not result in a fall, therefore is not related to this investigation.Based on the gathered evidence, the resident's fall was a result of improper selection of the mattress in relation to the bed frame.The arjo product was used for the resident treatment when the resident's fell occurred, therefore the mattress played a role, however there was no failure that would cause the fall.This complaint is deemed reportable due to allegation of a fall from arjo product.

• Brand Name: FIRST STEP CIRRUS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou; jiangsu TX 21502 4; CH 215024
• 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: 16275747
• MDR Text Key: 308521500
• Report Number: 3005619970-2023-00003
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization