MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. PRESSUREGUARD; MATTRESS CONTROL UNIT

Model Number 5900

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 06/07/2015

Event Type  Injury  

Event Description

The patient, requiring assistance for all movement, was lying in bed on sunday june 7, 2015 around 9:30pm.The 5900 control unit, which provides alternating air flotation to the mattress, was hanging from the foot board of the bed.The control unit hangers were not secure against the foot board causing a gap between the bed foot board and the rubber coated hanger.As the nursing staff was turning the patient, her big toe was caught in the gap (between the control unit hanger and the footboard) causing a cut in between the big toe and second toe.The cut did require stitches.

Manufacturer Narrative

This model has been on the market for over three years, with over (b)(4) units sold, and this is the first report of this nature (with very similar models on the market for 20 years).Control unit hanger / patient interface is already part of our risk analysis (ra) thus coating the hangers to help prevent this type of injury.All (b)(4) control units are sold with a strap to help better secure the control unit to the bed which is detailed in the user manual ifu.No corrective action will be taken.

• Brand Name: PRESSUREGUARD
• Type of Device: MATTRESS CONTROL UNIT
• 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: 4861957
• MDR Text Key: 5864938
• Report Number: 1041130-2015-00002
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2015

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: 5900
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75