MAUDE Adverse Event Report: HILL-ROM, INC. STRETCHER; STRETCHER, WHEELED

Catalog Number 74347

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Ed patient placed on stretcher.When patient laid down on stretcher, nurse noted blood on the sheet.Patient assessed and found to have no areas of bleeding.Patient immediately moved to another stretcher.Bloody stretcher then examined and found to have blood ooze from the mattress when weight placed to it.Mattress cover removed and underlying mattress foam found to be soaked with blood from previous ed patient.Stretcher/mattress had been cleaned per protocol in between patients.There were no tears or rips in the mattress cover.

• Brand Name: STRETCHER
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 star route 46 east; batesville IL *
• MDR Report Key: 4846824
• MDR Text Key: 16465700
• Report Number: 4846824
• Device Sequence Number: 1
• Product Code: FPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 74347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2015
• Patient Sequence Number: 1