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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000730
Device Problems Bent (1059); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the leg rest was bent.It was further reported that the cable 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 leg rest was bent.It was further reported that the cable was broken.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was reported that the foot section of the recliner would not close.This will result in an annoyance only issue as footrest not closing is an annoyance only and apparent to the caregiver.Additionally it is not likely to harm the patient as they could be assisted by caregiver if needed.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
PATIENT ROOM WALL SAVER RECL
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 Key3634075
MDR Text Key3986104
Report Number0001831750-2014-01448
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 01/22/2014
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 Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/22/2014
Initial Date FDA Received02/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/09/2014
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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