MAUDE Adverse Event Report: HILL-ROM TOTALCARE ICU BED

Device Problems Device Reprocessing Problem (1091); Fail-Safe Design Failure (1222)

Patient Problem Bacterial Infection (1735)

Event Date 10/27/2016

Event Type  Injury  

Event Description

I am writing about serious pt safety and infectious disease hazard posed by the "hill-rom" hospital beds used in the icu setting at most other hospitals across the united states.My wife has the past few days in a "hill-rom total care" icu bed.Today we noticed a very specific and serious problem.This is related to design defect in these beds' side railing.Specifically the side guard rail joints on my icu bed were contaminated with a substantial amount of biological debris from prior uses.I'm happy to provide you with pictures of this problem to you if necessary.This accumulation of biological debris in the hospital bed is related to the faulty (and exposed) design of these side-rail joints on the pt side of the bed, and the fact that they are not easily amendable to cleaning.One can see that many hospital beds will be affected by this problem, which will serve as a definite vector for dangerous micro-organisms and superbug - like fungus.C.Diff and (b)(6).The proximity of these joints to the pt's face, hands and any potential incisions or central venous access lines poses a very grave infectious disease hazard to many already vulnerable pts, including my wife.I've taken the liberty of informing (b)(6), about this hazard and have sent him the relevant pictures.Please be advised that here we are informing you of a serious and specific nidus/vector of hospital acquired infection caused by a specific design flaw in hospital beds manufactured by hill-rom.We do not believe that this is an "environmental services" problem at the local hospital she is currently hospitalized at ((b)(6)), as the bed's design and the location of these joints prohibit a thorough cleaning and disinfection between uses.Please be advised this is a potentially serious nationwide problem that is very likely to be serving as a vector for hospital acquired infections in icu's and hospitals across the united states.Dates of use: (b)(6) 2016.Diagnosed or reason for use: icu bed used following an oncologist operation.

• Brand Name: TOTALCARE ICU BED
• Type of Device: TOTALCARE ICU BED
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 6066787
• MDR Text Key: 58833132
• Report Number: MW5065694
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HILL-ROM TOTALCARE ICU BED: (B)(6) 2016 - CURRENT
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 70