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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECA CORP SECA WHEELED CART

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SECA CORP SECA WHEELED CART Back to Search Results
Model Number 402
Device Problem Component Falling (1105)
Patient Problem No Code Available (3191)
Event Date 03/05/2018
Event Type  malfunction  
Event Description
Both wheels on the end of the cart fell off when the cart was moved slightly during the weighing process, the parents caught the infant as it was sliding off the scale which was tilted. Manufacturer response for wheeled cart, custom made for the scale, seca (per site reporter) manufacturer was concerned and requested to be kept in the loop on the issue.
 
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Brand NameSECA
Type of DeviceWHEELED CART
Manufacturer (Section D)
SECA CORP
13601 benson ave
chino CA 91710
MDR Report Key7319859
MDR Text Key101766195
Report Number7319859
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number402
Device Catalogue Number402
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2018
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer03/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/07/2018 Patient Sequence Number: 1
Treatment
THE DEVICE THAT FAILED WAS A CART THAT A INFANT SC
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