MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. 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  

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.

• Brand Name: FIRST STEP CIRRUS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 16275748
• MDR Text Key: 308521546
• Report Number: 1419652-2023-00007
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/01/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2023
• Distributor Facility Aware Date: 01/03/2023
• Date Report to Manufacturer: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization