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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2972000000
Device Problem Unintended System Motion (1430)
Patient Problem Injury (2348)
Event Date 01/19/2017
Event Type  Injury  
Event Description
It was reported that the nurses were experiencing injuries from boosting patients that have slid down on the bed as the mattress slides down toward the footboard on the bed.The extent and type of injuries that the nurses experienced were not reported, nor was any medical intervention reported.No patient involvement and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was reported that the customer did not have any specific injuries related to this report, rather this was a general complaint regarding injuries to the staff.The issue was resolved for the customer by replacing the bottom covers.
 
Event Description
It was reported that the nurses were experiencing injuries from boosting patients that have slid down on the bed as the mattress slides down toward the footboard on the bed.The extent and type of injuries that the nurses experienced were not reported, nor was any medical intervention reported.No patient involvement and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - D
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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6339625
MDR Text Key67698149
Report Number0001831750-2017-00037
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 health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/12/2017
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? Yes
Device Operator No Information
Device Catalogue Number2972000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2017
Initial Date FDA Received02/17/2017
Supplement Dates Manufacturer Received01/19/2017
Supplement Dates FDA Received09/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/20/2015
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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