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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
Health Effect - Clinical Code Pressure Sore/Ulcer (2326)
Date of Event 04/11/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem 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
Common Device Name
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key7503572
Report Number0001831750-2018-00470
Device Sequence Number1550331
Product Code IKZ
UDI-Device Identifier07613327278392
UDI-Public07613327278392
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Catalogue Number2971000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2018
Initial Report FDA Received Date05/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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