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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECA SECA 403 BABY SCALE CART SCALE, PATIENT

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SECA SECA 403 BABY SCALE CART SCALE, PATIENT Back to Search Results
Model Number 403
Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 08/24/2020
Event Type  malfunction  
Event Description
A seca baby cart model 403 was dropped off in the clinical engineering department with one of its rear wheels detached. After inspection, it appears the rear wheel's slotted socket that held the wheel's bolt had expanded and worn. This baby cart's front wheels had already been remediated for a class 2 device recall where the front brake wheels could loosen and detach. Recall number z-1429-2020. Manufacturer response for baby scale cart, seca (per site reporter) they acknowledge and thank us for sharing. No further communications about this issue with the baby cart received.
 
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Brand NameSECA 403 BABY SCALE CART
Type of DeviceSCALE, PATIENT
Manufacturer (Section D)
SECA
13601 benson ave
chino CA 91710
MDR Report Key10754719
MDR Text Key213663390
Report Number10754719
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/22/2020,10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403
Device Catalogue Number4030000009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2020
Device Age2 YR
Event Location No Information
Date Report to Manufacturer10/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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