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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000710
Device Problems Break (1069); Unintended System Motion (1430)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2015
Event Type  malfunction  
Event Description
It was reported the backrest would not remain upright and could not support patient weight due to a broken crossbar.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported the backrest would not remain upright and could not support patient weight due to a broken crossbar.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Parts on order for repair.
 
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Brand Name
TREATMENT RECLINER
Type of Device
CHAIR, EXAMINATION AND TREATMENT
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 Key4888960
MDR Text Key6034660
Report Number0001831750-2015-00311
Device Sequence Number1
Product Code FRK
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 06/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3500000710
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/04/2015
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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