• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number FL19F
Device Problems Break (1069); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2014
Event Type  malfunction  
Event Description
It was reported by service report that the patient side rail was stuck in the lowest position due to a damaged cable.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
lucas fischhaber
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3926493
MDR Text Key4520624
Report Number0001831750-2014-03145
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 Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2014
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 Model NumberFL19F
Device Catalogue NumberFL19F
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/17/2014
Initial Date FDA Received07/10/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-