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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); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the recliner backrest was broken and would not support patient weight.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 recliner backrest was broken and would not support patient weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was reported that the recliner backrest was broken and would not support patient weight.Supplemental submitted as further investigation determined the backrest would lean back when weight was applied to the backrest, due to spongy backrest.This would result in caregiver annoyance additionally, it is not likely to harm the patient as and the recliner would still support weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur.
 
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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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3757390
MDR Text Key4418831
Report Number0001831750-2014-02918
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 03/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/27/2014
Initial Date FDA Received04/17/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/27/2014
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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