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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ELECTRIC MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO ELECTRIC MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number FL23SE
Device Problem Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2015
Event Type  malfunction  
Event Description
It was reported via repair work order that the casters were delaminating potentially resulting in reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results provided by the customer which confirmed there was reduced brake force due to delaminating casters.Casters will be replaced at the customer's discretion.Customer performed evaluation.
 
Event Description
It was reported via repair work order that the casters were delaminating potentially resulting in reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
ELECTRIC MED/SURG BED
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
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
rita moffitt
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5348252
MDR Text Key35544620
Report Number0001831750-2016-00001
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberFL23SE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2015
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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