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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MOBILE TREAT. REC. LY5007; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO MOBILE TREAT. REC. LY5007; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3300000020
Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the backrest was loose and would not support patient weight due to a faulty mechanism.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
No parts available.
 
Event Description
It was reported via repair work order that the backrest was loose and would not support patient weight due to a faulty mechanism.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
MOBILE TREAT. REC. LY5007
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 Key3660815
MDR Text Key4316501
Report Number0001831750-2014-02046
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 02/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3300000020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/12/2014
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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