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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS GEOMATTRESS MAX

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SPAN AMERICA MEDICAL SYSTEMS GEOMATTRESS MAX Back to Search Results
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.
 
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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 Key17710728
MDR Text Key322955840
Report Number1041130-2023-00002
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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 NumberGEOMATTRESS MAX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/07/2023
Initial Date FDA Received09/08/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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