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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 Problems Break (1069); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
Event Type  malfunction  
Event Description
It was reported the upright assembly would not stay up and damaged other components, requiring the entire calf support to be replaced.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Customer ordered parts and performed their own repairs.Customer performed own evaluation and ordered parts for repair.
 
Event Description
It was reported the upright assembly would not stay up and damaged other components, requiring the entire calf support to be replaced.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Pma/510(k)#: k950889.
 
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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 Key4806239
MDR Text Key5917091
Report Number0001831750-2015-00252
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 05/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2015
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? No
Date Manufacturer Received05/01/2015
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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