MedSun: Medical Device Problem Summaries
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
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.
|Device Manufacturer and Brand||Device 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.|
Product Classification. 21CFR880.6190 Sec. 880.6190. Mattress cover for medical purposes. Retrieved from:
Product Classification. 21CFR880.5550 Sec. 880.5550 Alternating pressure air flotation mattress. Retrieved from:
All Medical Device Problem Summaries to Date
Updated December 12, 2013