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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HARD MANUFACTURING CO., INC. SPRINGFIELD CRIB; BED, PEDIATRIC OPEN HOSPITAL
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HARD MANUFACTURING CO., INC. SPRINGFIELD CRIB; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number E1843-CGP
Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)
Patient Problem Fall (1848)
Event Type  malfunction  
Event Description
Infant patient was in the crib and as the child leaned against the railing, it dropped and the patient fell out of the crib.Parents were in the room and stated that it happened so fast.Parents immediately picked up the child with no apparent harm.The crib was evaluated with no apparent malfunction.The nurse felt the bed malfunctioned as the rail apparently did not lock.When i examined several similar cribs and raised the side rail, i noted that several times the right side did not latch.Is this an issue elsewhere? do the rails need some way to identify that both sides are secure?.
 
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Brand Name
SPRINGFIELD CRIB
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
HARD MANUFACTURING CO., INC.
230 grider st.
buffalo NY 14215
MDR Report Key6313763
MDR Text Key66877216
Report Number6313763
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberE1843-CGP
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2017
Event Location Hospital
Date Report to Manufacturer02/06/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2017
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 Age1 YR
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