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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STEEL CHAIR; CHAIR AND TABLE, MEDICAL
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STRYKER MEDICAL-KALAMAZOO STEEL CHAIR; CHAIR AND TABLE, MEDICAL Back to Search Results
Catalog Number 3500000520
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2015
Event Type  malfunction  
Event Description
It was reported via repair work order that the weld on the chair frame was broken.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported via repair work order that the weld on the chair frame was broken.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Parts have been ordered for repair.
 
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Brand Name
STEEL CHAIR
Type of Device
CHAIR AND TABLE, MEDICAL
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 Key4868352
MDR Text Key6016913
Report Number0001831750-2015-00290
Device Sequence Number1
Product Code KMN
Combination Product (y/n)N
Reporter Country CodeUS
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 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3500000520
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/29/2015
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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