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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number FL19H
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.  6 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.  there was no remedial action taken.  this device is not labeled for single use.
 
Event Description
This report summarizes 8 malfunction events, where it was reported there was an unexpected siderail drop/collapse or the canopy does not remain in raised position.There was no patient involvement.
 
Manufacturer Narrative
The final 2 devices were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.
 
Event Description
This report summarizes 8 malfunction events, where it was reported there was an unexpected siderail drop/collapse or the canopy does not remain in raised position.There was no patient involvement.
 
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Brand Name
CUB PEDIATRIC CRIB- HYD BASE
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11715602
MDR Text Key248046426
Report Number0001831750-2021-00834
Device Sequence Number1
Product Code FMS
UDI-Device Identifier07613327169348
UDI-Public07613327169348
Combination Product (y/n)N
Number of Events Reported8
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberFL19H
Device Catalogue NumberFL19H
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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