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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19F
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.3 devices were evaluated in the field and the issue was confirmed; there were broken/damaged components.The devices were repaired and returned.There was no remedial action taken.These devices are not labeled for single use.
 
Event Description
This report summarizes 3 malfunction events, where it was reported there was a false latch of the siderail or the siderail could not be latched.There was no patient involvement.
 
Manufacturer Narrative
It was originally reported that all 3 devices were evaluated in the field; however, it was determined one of the devices was not made accessible for testing.
 
Event Description
This report summarizes 3 malfunction events, where it was reported there was a false latch of the siderail or the siderail could not be latched.There was no patient involvement.
 
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Brand Name
CUB PEDIATRIC CRIB- FIXED BASE
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10747750
MDR Text Key213467961
Report Number0001831750-2020-01159
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/21/2021
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 Operator Health Professional
Device Catalogue NumberFL19F
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received10/01/2020
Supplement Dates FDA Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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