MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE GURNEY MATTRESS; MATTRESS, FLOTATION THERAPY

Catalog Number MDTS2676H4C

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Two events involving medline gurney mattress (b)(6) 2018: pt had intravenous fluid catheter inserted, which returned blood upon insertion.Blood pooled on mattress through sheet.On (b)(6) 2018: trauma pt with multiple injuries bled on gurney.Both mattresses were being cleaned per mfr guidelines following the use on the above mentioned pts.Routine cleaning process did not find any blood.Breaks, pokes visible to the eye on the mattress.However, when a white towel was placed on the individual mattress and pressure applied, bright red blood was seen on the white towel.Mattresses were removed from use and placed in biohazard bags.Kept for mfr's rep to pickup for investigation.

• Brand Name: MEDLINE GURNEY MATTRESS
• Type of Device: MATTRESS, FLOTATION THERAPY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; mundelein IL 60060
• MDR Report Key: 7797416
• MDR Text Key: 117831251
• Report Number: MW5079236
• Device Sequence Number: 2
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDTS2676H4C
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1