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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LD304 MATERNITY BED; TABLE, OBSTETRICAL, AC-POWERED AND ACCESSORIES
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STRYKER MEDICAL-KALAMAZOO LD304 MATERNITY BED; TABLE, OBSTETRICAL, AC-POWERED AND ACCESSORIES Back to Search Results
Catalog Number 4701000000
Device Problem Component Falling (1105)
Patient Problem Fall (1848)
Event Date 02/08/2015
Event Type  malfunction  
Event Description
It was reported by the user facility that a patient was seated on the end of the bed, and the foot section fell off, and the patient fell to the floor.It was reported that about an hour later, the same event occurred again.No injury was reported to the patient.The user facility staff was not able to duplicate the alleged event.
 
Event Description
It was reported by the user facility that a patient was seated on the end of the bed, and the foot section fell off, and the patient fell to the floor.It was reported that about an hour later, the same event occurred again.No injury was reported to the patient.The user facility staff was not able to duplicate the alleged event.
 
Manufacturer Narrative
Follow-up submitted with evaluation results.The technician inspected the bed and was unable to duplicate the malfunction.No defect was found with the foot section.
 
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Brand Name
LD304 MATERNITY BED
Type of Device
TABLE, OBSTETRICAL, AC-POWERED AND ACCESSORIES
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 Key4587682
MDR Text Key18932690
Report Number0001831750-2015-00106
Device Sequence Number1
Product Code HDD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K950889
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4701000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2015
Was Device Evaluated by Manufacturer? Yes
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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