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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Catalog Number UNK_MED
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pressure Sores (2326)
Event Date 10/04/2021
Event Type  Injury  
Event Description
It was reported that patients are developing pressure sores while using a stryker powered surface.The severity and treatment for pressure sores is currently unknown and attempts have been made to the user facility to gather more details.
 
Manufacturer Narrative
This supplemental record is being filed to correct the device problem code.
 
Event Description
It was reported that patients are developing pressure sores while using a stryker powered surface.The user facility did not keep a record of the frequency, severity, cause, or treatment of the pressure injuries.The user facility also stated that the type of surface these occurred on was not recorded and it was either a low air loss surface or an inflatable mattress overlay.Through further investigation it was determined that the user facility was experiencing an issue with a stryker air+ pump, which provides power for low air loss surfaces and inflation for mattress overlay surfaces.Additionally, the overlay is intended to be used in combination with a powered surface.If the air plus pump were to experience an issue the patient would still be laying on a support surface that would function as intended without the use of the pump.Additionally, the low air loss feature is optional and the surface can be used with or without it.The issue experienced with the air+ pump is not reportable and was investigated under another complaint record.Additionally, there are many clinical factors relevant to the development of pressure injuries including: poor patient skin condition, moisture from surface, and patient mobility.The user facility did respond to attempts to gather these details; however, based on the information provided there was no defect or malfunction with the surface that would have caused or contributed to the pressure injuries.
 
Event Description
It was reported that patients are developing pressure sores while using a stryker powered surface.The user facility did not keep a record of the frequency, severity, cause, or treatment of the pressure injuries.The user facility also stated that the type of surface these occurred on was not recorded and it was either a low air loss surface or an inflatable mattress overlay.Through further investigation it was determined that the user facility was experiencing an issue with a stryker air+ pump, which provides power for low air loss surfaces and inflation for mattress overlay surfaces.Additionally, the overlay is intended to be used in combination with a powered surface.If the air plus pump were to experience an issue the patient would still be laying on a support surface that would function as intended without the use of the pump.Additionally, the low air loss feature is optional and the surface can be used with or without it.The issue experienced with the air+ pump is not reportable and was investigated under another complaint record.Additionally, there are many clinical factors relevant to the development of pressure injuries including: poor patient skin condition, moisture from surface, and patient mobility.The user facility did respond to attempts to gather these details; however, based on the information provided there was no defect or malfunction with the surface that would have caused or contributed to the pressure injuries.
 
Manufacturer Narrative
The user facility did not keep a record of the model or serial number of the surfaces involved, therefore a device evaluation was not able to be completed.The investigation has been completed and additional details have been provided under section b5.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
kelsey barla
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key12738067
MDR Text Key279588739
Report Number0001831750-2021-01620
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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