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U.S. Department of Health and Human Services

MedSun: Medical Device Problem Summaries

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Medical Device Problem Summaries

Here you will find medical device problems summarized from reports received by MedSun hospitals.

Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem with Mattress Covers
(From Newsletter #73, June 2012)

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Mattress covers are described in FDA regulations under 21 CFR 880.6190 as, "A mattress cover for medical purposes, intended for medical purposes, used to protect a mattress. The mattress cover may be electrically conductive or contain a germicide" (Food and Drug Administration Product Code Classification, 2012).

Mattress covers may be also be considered part of an alternating pressure air flotation mattress. An alternating pressure air flotation mattress is, “a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).” (Food and Drug Administration Product Code Classification, 2012)

Over the past 2 years, MedSun has received 5 adverse event reports with mattress covers manufactured by Encompass Therapeutic Support Systems, Hill-Rom, Stryker Medical, and Tempur-Pedic North America. The reports were submitted by 5 hospitals between January 2009 and May 2012.

The reported device problems were:
• Foul odor permeating from the mattress - 2
• Mattress cover allowed fluids to backflow from the core to the outside of the cover – 2
• Mattress cover was noted to have deteriorated allowing fluid ingress - 2
• Mattress core contained stains - 1
• Compromised zippered mattress overlay allows penetration of blood/body fluids - 1
• Manufacturer’s guidelines or protocols unclear regarding the suggested frequency of laundering mattress overlays and/or proper disinfection between patient uses - 1
• Leaks appearing to have come from the mattress cover seams - 1

None of the reports involved patient death or serious injuries.

The following were potential harms mentioned in the reported events:
• Patient exposed to fluids that seeped up from the mattress core
• Potential to cause patient exposure to communicable diseases

None of the reports listed patient age. A single report listed patient sex, which was a male patient. Two hospitals informed having over 20 mattresses compromised in their facility.

These MedSun reports listed above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

There are no device recalls associated with mattresses since 2009.

The following table lists MedSun reports that are described in the device problem summary above. Please note, the reports have been edited for clarity.

MedSun Reports Describing Problems with Mattress Covers
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Stryker Medical, XPRT Sleep Surface NA, NA, H50045
A bed found at our facility in a storage area and was noted to have a foul odor. It had recently been used and removed from service due to the odor. Engineering unzipped the mattress cover because of the odor. The mattress inside was found to be covered in red foul-smelling fluid.

The mattress was examined and there were no holes, tears or cuts noted in the cover. The mattress was contained and wrapped by hospital personnel.

It was noted by staff that the bed had been recently worked on by the Stryker staff, and the foul odor was mentioned to the representative.
Stryker Medical, Isoflex NA, 100212000, NA
The Stryker silver top mattress was found to have dark small rounds spots on it which appeared to be possible mold.
Encompass Therapeutic Support Systems, Accumax Quantum Complete NA, AK-169N10-384, NA
Mattresses on low flow beds used in critical care unit revealed compromised zippered mattress overlays, allowing penetration of blood/body fluids into the internal cotton layer, which has the potential to cause patient exposure to communicable diseases when the fluids seep back up. Also, black overlays make this issue more difficult to identify. Marketing materials states routine surface cleaning sufficient and that material prevents leakage but now mfg. Stating overlays should be laundered every 90 days or when saturated.
Hill-Rom, Inc. NA, NA, NA A patient was admitted to a bed. The mattress cover was noted to have "deteriorated" and subsequently allowed fluids stored in the mattress foam to seep upwards through the cover up through the sheets. Upon examination, there were breaks in the mattress liner appearing that fluid had accumulated into the foam and when the patient’s weight compressed the foam, fluids seeped back through the non-intact cover staining the sheets with a fluid substance that was red-tinged.

These mattresses were thought to have a non-permeable cover that protected them from absorbing any fluids into the mattress foam or cushion.

After the first bed was identified, the manufacturer scheduled 2 days to assist in the evaluation of beds at the system's two largest hospitals. The institution realized that these mattresses have a one year warranty and this time frame was exceeded in many instances. The contracted housekeeping service followed our Infection Control Department guidelines for cleaning the mattresses but did not routinely unzip and check the integrity of the liners. Hill-Rom is contracted to do preventive maintenance on the hardware or the mechanics of the beds but not the mattresses. Multiple beds in the facility were identified as being at risk of non-permeable barriers and protection from body fluids.
Tempur-Pedic North America, Inc., Medical Division, Tempur Med Pressure reducing Product
NA, 5767277, NA We have discovered in two (2) different departments in the facility blood & mold stains on the cushions that are within an impermeable cover. The cushion and cover are manufactured by one company but sold by another company as part of their procedure table for the Interventional Radiology Department and Endovascular Lab.


Additional Information:

Product Classification. 21CFR880.6190 Sec. 880.6190. Mattress cover for medical purposes. Retrieved from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6190.

Product Classification. 21CFR880.5550 Sec. 880.5550 Alternating pressure air flotation mattress. Retrieved from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5550.

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All Medical Device Problem Summaries to Date

TitleDate
Summary of MedSun Reports Describing Problem with Mattress CoversJune 2012
Summary of MedSun Reports Describing Problems With Chemotherapy Transfer DevicesApril 2012
Summary of MedSun Reports Describing Problem With the Continuous Cardiac Output Pulmonary Artery CatheterFebruary 2012
Summary of MedSun Reports Describing Problem with Intraocular LensesDecember 2011
Summary of MedSun Reports Describing Problem Gastrointestinal Tubing and AccessoriesOctober 2011
Summary of MedSun Reports Describing Problems With Implanted Subcutaneous Ports and CathetersSeptember 2011
Summary of MedSun Reports Describing Problem With Coronary StentsAugust 2011
Summary of MedSun Reports Describing Problems With External Defibrillation and Multifunction ElectrodesJuly 2011
Summary of MedSun Reports Describing Problems With Ultrasonic Surgical InstrumentsJune 2011
Summary of MedSun Reports Describing Problems With Specimen Retrieval SystemsMay 2011
Summary of MedSun Reports Describing Problem With Patient AC-Powered LiftsApril 2011
Summary of MedSun Reports Describing Problem With Arthroscopic Shaver Blades and BurrsMarch 2011
Summary of MedSun Reports Describing Adverse Events With Sterilization Process IndicatorsFebruary 2011
Summary of MedSun Reports Describing Adverse Events With Anesthesia or Analgesia Gas MachinesJanuary 2011
Summary of MedSun Reports Describing Adverse Events With Cardiovascular Programmable Diagnostic ComputersDecember 2010
Summary of MedSun Reports Describing Adverse Events With Thermal Regulating SystemsNovember 2010
Summary of MedSun Reports Describing Adverse Events With Arthroscopy PumpsOctober 2010
Summary of MedSun Reports Describing Adverse Events Involving Foley CathetersSeptember 2010
Summary of MedSun Reports Describing Adverse Events With Peripherally Inserted Central CathetersAugust 2010
Summary of MedSun Reports Describing Adverse Events With External Infusion PumpsJuly 2010
Summary of MedSun Reports Describing Adverse Events With Fallopian Tubal Occlusion Devices (TOD)June 2010
Summary of MedSun Reports Describing Adverse Events Involving Surgical Laser FibersMay 2010
Summary of MedSun Reports Describing Events With Physiological Monitoring Systems with Software IssuesApril 2010
Summary of MedSun Reports Describing Adverse Events With Infusion Tubing used with Power InjectorsMarch 2010
Summary of MedSun Reports Describing Adverse Events With IV CathetersFebruary 2010
Summary of MedSun Reports Describing Adverse Events With Patient-Controlled Analgesia (PCA) PumpsFebruary 2010
Summary of MedSun Reports Describing Adverse Events Concerning Cochlear ImplantsJanuary 2010
Summary of MedSun Reports Describing Adverse Events With Hot Disposable PacksJanuary 2010
Summary of MedSun Reports Describing Adverse Events With Magnetic Resonance Imaging Machine (MRI)December 2009
Summary of MedSun Reports Describing Adverse Events With Brachytherapy CathetersDecember 2009
Summary of MedSun Reports Describing Adverse Events With Breast Tissue ExpandersNovember 2009
Summary of MedSun Reports Describing Adverse Events With External DefibrillatorsOctober 2009
Summary of MedSun Reports Describing Adverse Events With Troponin AssaysOctober 2009
Summary of MedSun Reports Describing Adverse Events With Point-of-Care (POC) Glucose MetersSeptember 2009
Summary of MedSun Reports Describing Adverse Events With Coagulation Monitoring DevicesSeptember 2009
Summary of MedSun Reports Describing Adverse Events With Adjustable Gastric Banding SystemAugust 2009
Summary of MedSun Reports Describing Adverse Events With Vascular Hemostasis DevicesJuly 2009
Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Fire Associated ReportsJuly 2009
Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Patient BurnsJuly 2009
Summary of MedSun Reports Describing Adverse Events With Cardiac RF Ablation CathetersJune 2009
Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia RepairMay 2009
Summary of MedSun Reports Describing Adverse Events With Ventricular Assist DevicesApril 2009
Summary of MedSun Reports Describing Adverse Events With Integra LifeSciences Corp.'s MAYFIELD Skull ClampMarch 2009
Summary of MedSun Reports Describing Adverse Events With "Harmonic Scalpel" Ultrasonic Surgical InstrumentsMarch 2009
Summary of MedSun Reports Describing Adverse Events: Large Volume Infusion Pumps and Issues Resulting In Over-infusionFebruary 2009
Summary of MedSun Reports Describing Adverse Events with the Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery SystemFebruary 2009
Summary of MedSun Reports Describing Adverse Events With the ConMed VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) Uterine ManipulatorJanuary 2009
Summary of MedSun Reports Describing Adverse Events With Arthroscopic Pumps/TubingDecember 2008
Summary of MedSun Reports Describing Adverse Events With Long Term Intravascular Catheters and Related ArticleNovember 2008
Summary of MedSun Reports Describing Adverse Events With Infusion Pumps in Pediatric Patients and Related ArticlesOctober 2008
Summary of MedSun Reports Describing Adverse Events With Electrocardiograph Electrodes in Pediatric Patients and Related ReferenceSeptember 2008
Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems in Pediatric Patients and Related ReferenceSeptember 2008
Summary of Medical Device Adverse Event Reports Describing Adverse Events With Umbilical Artery Catheters And Related ArticleAugust 2008
Summary of MedSun Reports Describing Adverse Events With Infant Radiant Warmers and Neonatal Incubators And Related Recalls and ArticlesAugust 2008
Summary of MedSun Reports Describing Adverse Events With High Frequency Oscillatory VentilatorsJune 2008
Summary of MedSun Reports Describing Adverse Events With Cranial PerforatorsJune 2008
Summary of MedSun Reports Describing Adverse Events With Transcatheter Septal OccludersMay 2008
Summary of MedSun Reports Describing Adverse Events With da Vinci Surgical DevicesNovember 2007

Updated October 22, 2014

Return to MedSun: Medical Product Safety Network

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