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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HARD MFG. CO., INC. HARD; BED, PEDIATRIC OPEN HOSPITAL
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HARD MFG. CO., INC. HARD; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number 12568
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
Numerous hard cribs have failed; the zip-ties, provided by the company, to hold the plastic topper of the crib are breaking.During the initial installation of the crib, the zip-ties broke making the plastic screen of the crib useless.The company provided the hospital with stronger zip-ties.However, the have been multiple issues with the stronger zip-ties breaking too.The hard cribs are under expected patient use, and there is nothing heavy being held in the plastic topper pockets.There is a possibility of patient harm when the zip-ties break, and the plastic topper can no longer prevent a child from climbing over the crib.The company has been contacted, and they are again sending extra tensile zip-ties for this issue.Manufacturer response for crib, hard (per site reporter).Manufacturer has responded by sending more zip-ties.Hard reported that they did not have reports of this issue from other sites.
 
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Brand Name
HARD
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
HARD MFG. CO., INC.
230 grider st
buffalo NY 14215
MDR Report Key16408295
MDR Text Key309874202
Report Number16408295
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/06/2023
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 Model Number12568
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2023
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer02/21/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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