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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number UNK_MED
Device Problem Material Too Soft/Flexible (4007)
Patient Problem Pressure Sores (2326)
Event Date 11/12/2020
Event Type  Injury  
Event Description
It was reported that an unspecified isolibrium mattress had deflated due to a nurse engaging the cpr release and that the staff had incorrectly assumed an alarm would go off if the mattress was left deflated.There was no defect with the product as it operated as designed.As a result of laying on the deflated mattress for an extended period of time the patient developed a deep tissue injury.The injury was treated with an ointment.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key10992999
MDR Text Key220963572
Report Number0001831750-2020-01218
Device Sequence Number1
Product Code IKZ
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 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/13/2020
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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