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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED

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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2971000000
Device Problem Insufficient Information (3190)
Patient Problem Pressure Sores (2326)
Event Date 04/11/2018
Event Type  Injury  
Manufacturer Narrative
The nurse manager indicated she believed the injury may be attributed to the mattress cycling out of prevention mode.She was informed by a stryker quality assurance engineer that the mattress may leave prevention mode if the power of the unit is cycled and patient therapy settings are not reselected.The nurse manager reported the account is working on training measures to educate nurses to check to make sure the bed is in prevention mode.No device malfunction is alleged.
 
Event Description
It was reported the patient developed a stage 3 pressure injury while on the mattress.The nurse manager reported the injury was treated using venelex.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - N
Type of Device
BED, PATIENT ROTATION, POWERED
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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7503572
MDR Text Key107892478
Report Number0001831750-2018-00470
Device Sequence Number1
Product Code IKZ
UDI-Device Identifier07613327278392
UDI-Public07613327278392
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
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2971000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/08/2018
Initial Date FDA Received05/10/2018
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
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