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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ADEL OBS 6/04; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
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STRYKER MEDICAL-KALAMAZOO ADEL OBS 6/04; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) Back to Search Results
Catalog Number 4700000000
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the footsection would not latch due to a broken weldment.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental report submitted to add the 510(k) number for the product.
 
Event Description
It was reported via repair work order that the footsection would not latch due to a broken weldment.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
ADEL OBS 6/04
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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4418389
MDR Text Key5318398
Report Number0001831750-2015-00015
Device Sequence Number1
Product Code HDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950889
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4700000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/20/2014
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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