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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM ROCKER RECLINER; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO PATIENT ROOM ROCKER RECLINER; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000750
Device Problem Unintended System Motion (1430)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2015
Event Type  malfunction  
Event Description
It was reported via repair work order that recliner gave way with a patient in the recliner.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with additional information provided by customer's evaluation.Revised executive summary to state the recliner would not lock in the closed position due to a bent mechanism.Conclusion - part was sent to customer to perform repair.Customer performed evaluation.
 
Event Description
It was reported via repair work order that recliner gave way with a patient in the recliner and would not lock in the closed position due to a bent mechanism.The patient was not affected, no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
PATIENT ROOM ROCKER 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 Key4916555
MDR Text Key22392253
Report Number0001831750-2015-00354
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
Report Date 06/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3500000750
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/20/2015
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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