MAUDE Adverse Event Report: STRYKER CORPORATION ISOFLEX SE; MATTRESS, FLOTATION THERAPY, NON-POWERED

Device Problems Fungus in Device Environment (2316); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

We believe we have discovered a systemic defect in stryker isoflex se leading to chronic mold accumulation from fluid invasion.We attribute this contamination due to the presence of stryker's heat melded logo/design on their surface cover.This assumption is based upon the nature/characteristics of the contamination.The fluid invasion is occurring in the same pattern as the heat melded stryker logo and design on the stryker mattress top or "support surface".We initially discovered this issue in 2021, leading stryker to replace our fleet of ed (emergency department) mattresses/support surfaces (80 total) due to the same pattern of fluid invasion with corresponding mold build-up.Moving forward to this past week, one of our technicians uncovered the same exact failure during a regularly scheduled pm (preventative maintenance) of the mattresses.Deterioration of the fire barrier between the mattress and cover was also identified.We again communicated the presence of this contamination and seeming defect to stryker.This time, instead of engaging in a conversation about a possible systemic defect in their equipment they put the onus on our facility citing their ifu cleaning and the recommended 12-month window of replacement.Following this response, we verified the mold to be present underneath mattress tops still within the 12-month window.As far as following the correct cleaning ifu, we believe this to be a moot point as the mold is only present where the heat melded design and logo appear.To further this point, no mold has been found underneath stretcher support surfaces which do not bear the stryker logo (ultra comfort se) as well as in our pacu (post anesthesia care unit) mattresses using the stryker (comfortgel se), which are all cleaned in the same manner.For the sake of transparency, our stretcher support surfaces are cleaned by our evs (environmental services) team with peracetic acid; a widely used cleaning solution within hospital facilities.We posit stryker cannot in good faith claim there to be something incorrect in our cleaning process when the fluid invasion and subsequent mold only occurs beneath their heat melded design/logo present on the stryker isoflex mattress surface cover.The absence of this defect in their other models of mattress toppers we possess only strengthens this assertation.Furthermore, we wish to warn other hospitals of this potential fluid invasion that we believe likely to occur with the isoflex se stretcher support surface from stryker.Manufacturer response for stretcher support surface, isoflex se (per site reporter)."i am sorry to see that this issue is surfacing again.Let us know how we can support.I do know that if the covers have not been replaced within the 12-month recommended window and the ifu cleaning was not followed at any point, then this is not a device/manufacturing issue per the fda.As always, we are at the ready to support your facility in any decision making/discussions/evaluations/etc.".

• Brand Name: ISOFLEX SE
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 15437593
• MDR Text Key: 300042790
• Report Number: 15437593
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022,08/30/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1