MAUDE Adverse Event Report: STRYKER MEDICAL STRYKER ISOTOUR MATTRESS COVER; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	2872
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On or about march 14, 2024 we identified tearing in the corner seams of one stryker isotour premium mattresses.We inspected other mattresses in the same corner areas and found numerous mattresses with similar tears.We reached out to the manufacturer as these were only approximately 2 years old and under warranty.They initially sent 25 replacement mattress covers while their quality team investigated.These 25 new covers began to have similar tearing with just a few weeks.Meanwhile, our facility team evaluated internal practices to ensure we were following the instructions for use for handling and cleaning.We were able to validate we were following appropriate processes per the provided instructions for use.Meanwhile, we continued to have tearing issues at the seams.On may 31st we received communication from stryker that the preliminary findings from the quality team were not quality product issues but the likely result of our mishandling.Citing this as an isolated incident in our facility.We reached out to local facilities also using these same mattresses and conducted site visits on 8.13.24 at three facilities: (b)(6) all three locations are experiencing the same issue with tearing in the corner weld seams.These locations were not aware until our site visits to discuss the issues we were having.On 8.14.24, we notified stryker, and on 8.15.24, we had a virtual meeting where we were offered a 1x replacement cover for each of our mattresses as well as no-cost training to our staff.We appreciate the willingness to rectify this issue; however, we have reservations regarding product quality as the claim is still that it is an internal handling issue even though multiple facilities are experiencing the issue.These devices are class i and class ii devices.Penetrations in the mattress cover can allow blood and body fluids to enter the gel inner core and render them difficult/unable to clean.Per the fda safety alert regarding this in 2013 this poses risk of patient infection.These products appear to be defective, and our concern is that patients are being placed at risk on a larger scale than just our facility and the regional colleagues we have identified.Reference reports: mw5158662, mw5158663, mw5158664, mw5158665, mw5158666, mw5158668, mw5158669, mw5158670, mw5158671, mw5158672, mw5158673, mw5158674, mw5158675, mw5158676, mw5158677, mw5158678, mw5158679, mw5158680, mw5158681, mw5158682, mw5158683, mw5158684, mw5158685, mw5158686.Refer to additional documents in i2k.

• Brand Name: STRYKER ISOTOUR MATTRESS COVER
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL; MI
• MDR Report Key: 20033942
• Report Number: MW5158667
• Device Sequence Number: 7677232
• Product Code: FNM
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown