MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS; Mattress, air flotation, alternating pressure

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Span america was notified on (b)(6) 2023 that a patient fell out of bed and sustained a fracture.The facility was contacted by phone and email on 12/13/2023 to obtain additional information but they were unwilling to provide any further details.They did not provide the incident date, specific product, or patient details.

Event Description

Facility stated a veteran fell out of bed and had a fracture.They did not provide the incident date, specific product, or patient details.The facility was contacted by phone and email and was unwilling to provide any further details.

• Type of Device: Mattress, air flotation, alternating pressure
• 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: 18344325
• MDR Text Key: 330799038
• Report Number: 1041130-2023-00004
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• 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): Other