MAUDE Adverse Event Report: LINET AMERICAS SYMBIOSO INTEGRATED LOW AIR LOSS MATTRESS

Model Number 3VS0SD0220000

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

Outer cover of the symbioso mattress failed to prevent bodily fluid from leaking into the body of the mattress.Fluid leakage has been found on multiple occasions by (b)(6)during cleaning of beds in the intensive care unit.Had this leakage not been found, potential exists to place a new pt on a mattress that contains bodily fluid from a previous pt.Multiple complaints have been lodged with the manufacturer of the mattress.Fluid leaked through the top cover, past the air bladders through a foam filled layer to the very bottom outer cover of the mattress.We have provided previous samples of failed covers to the manufacturer.

• Brand Name: SYMBIOSO INTEGRATED LOW AIR LOSS MATTRESS
• Type of Device: LOW AIR LOSS MATTRESS
• Manufacturer (Section D): LINET AMERICAS; 10420-r harris oak blvd; charlotte NC 28216
• MDR Report Key: 3851399
• MDR Text Key: 4685656
• Report Number: MW5036457
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3VS0SD0220000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1