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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 SIGNATURE - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

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STRYKER MEDICAL-KALAMAZOO S3 SIGNATURE - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 3005S3SIGNATURE
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the bed would not move when using hi/lo.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 bed would not move when using hi/lo due to lift coupler malfunctions.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results provided by customer which determined the bed not moving when using hi/lo was due to lift coupler malfunctions.Customer sent parts to do repairs.Customer performed evaluation.
 
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Brand Name
S3 SIGNATURE - 3005
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
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 Key3693735
MDR Text Key4258560
Report Number0001831750-2014-02549
Device Sequence Number1
Product Code FNL
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 02/25/2014
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 Number3005S3SIGNATURE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/25/2014
Initial Date FDA Received03/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/25/2014
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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