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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL SECURE 3002 EX; BED, AC-POWERED ADJUSTABLE HOSPITAL

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STRYKER MEDICAL SECURE 3002 EX; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 3002EX
Device Problems Device Maintenance Issue (1379); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 09/07/2015
Event Type  malfunction  
Event Description
Bed scale not working indicated system error and service needed.
 
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Brand Name
SECURE 3002 EX
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL
3800 east centre avenue
portage, MI 49002
MDR Report Key5142238
MDR Text Key27992170
Report Number5142238
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 User Facility
Reporter Occupation Other
Report Date 09/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number3002EX
Other Device ID NumberCONTROL # 41810
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2015
Event Location Hospital
Date Report to Manufacturer09/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age63 YR
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