MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. PRESSUREGUARD APM; ALTERNATING PRESSURE MATTRESS

Model Number AP8448-29

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The event which occurred consisted of a span america alternating pressure mattress and a competitor's bed.Although this is an alternating pressure mattress, which is excluded from the entrapment guidance, our mattress is designed with a firm perimeter (unlike most air mattresses) to provide a safer surface for entrapment and side sitting stablity.Based on an analysis of our post production risk management and the design safety features already present on this product; no action is required.

Event Description

The patient was found on his knees on the floor with his head entrapped between the end of the 1/2 rail and the alternating pressure mattress.There was no injury involved in event.

• Brand Name: PRESSUREGUARD APM
• Type of Device: ALTERNATING PRESSURE MATTRESS
• Manufacturer (Section D): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer (Section G): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer Contact: william darby ; 70 commerce center; greenville, SC 29615 ; 8646786936
• MDR Report Key: 6177003
• MDR Text Key: 62521899
• Report Number: 1041130-2016-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

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: Health Professional
• Device Model Number: AP8448-29
• Device Catalogue Number: AP8448-29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1