MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS GEOMATTRESS MAX

Model Number GEOMATTRESS MAX

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 07/04/2023

Event Type  Death  

Event Description

Patient death due to entrapement between the mattress and the side rail.

Manufacturer Narrative

Patient died entrapped between the mattress and side rail on (b)(6) 2023.Mattress manufacturer was notified on 09/07/2023 by importer.Importer conducted an investigation on 08/31/2023.Sales representative conducted an investigation of the bed frame on 09/05/2023.It is believed that the nursing home assembled the beds themselves.It is unknown by the administrator / director of care exactly how this would of happened.What is known: bed was properly setup.Rails were not loose.Geomattress max mattress was the surface used and it was in position inside the 4 corner brackets and is the correct size for the bed.The resident was found deceased between the rail and the mattress by the edge of the side rail (in the area of zone 4 of the ½ head rail) (b)(6) 2023.The rounded part of the rail towards the foot-end of the bed.A thorough overall review of the bed was conducted by the facility, importer and manufacturer representative and they were unable to find any faulty conditions.No autopsy was performed.Actual cause of death is unknown.The investigation found no issues.This is the first reported death on this surface.The geo-mattress max is designed with a firm perimeter.It is documented to meet hospital bed safety workgroup (hbsw) dimensional guidelines as published in the fda's hospital bed system dimensional and assessment guidance to reduce entrapment and health canada's guidance document adult hospital beds: patient entrapment hazards, side rail latching reliability, and other hazards when used in conjunction with appropriately sized span beds, such as the advantage bed, assist devices, rails, head and footboards.Given the information and investigation, no corrective action is needed at this time.

Event Description

Patient death due to entrapment between the mattress and the side rail.

Manufacturer Narrative

Initial report was sent as a 5 day report in error.A 30 day report should have been selected.

• Brand Name: GEOMATTRESS MAX
• Type of Device: MATTRESS
• Manufacturer (Section D): SPAN AMERICA MEDICAL SYSTEMS; 70 commerce center; greenville SC 29615
• Manufacturer (Section G): SPAN AMERICA MEDICAL SYSTEMS; 70 commerce center; greenville SC 29615
• Manufacturer Contact: erika ramsbottom ; 70 commerce center; greenville, SC 29615 ; 8646786959
• MDR Report Key: 17710728
• MDR Text Key: 322955840
• Report Number: 1041130-2023-00002
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GEOMATTRESS MAX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/20/2023
• 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): Death