MAUDE Adverse Event Report: HILL-ROM, INC. ACCUMAX QC COMPLETE 35X84X7; MATTRESS

Model Number PAISF9310384

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/23/2015

Event Type  Other  

Event Description

Hill-rom received a report form a hill-rom sales representative stating, that the accumax qc complete surface was contaminated by body fluids form an hiv positive patient with a gastrointestinal bleed that had soaked through the mattress.A second patient was placed on the mattress and was exposed to the body fluids.The second patient was clothed and had no open wounds.Second patient had a history of cystic fibrosis, she was placed on post exposure prophylaxis medication for duration of 28 days.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Hill-rom has requested the return of the mattress topper for evaluation.The user facility has not returned the device, therefore, we are unable to determine if the device malfunctioned or had a breach in the surface.If additional information related to this event becomes available, a follow up report will be filed.

• Brand Name: ACCUMAX QC COMPLETE 35X84X7
• Type of Device: MATTRESS
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jill burnett ; 1069 state rte 46 e; batesville, IN 47006 ; 8129312901
• MDR Report Key: 4544722
• MDR Text Key: 5509044
• Report Number: 1824206-2015-00256
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

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: PAISF9310384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR