Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 STRETCHER; 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 STRETCHER; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number 0190000000
Device Problems Device Slipped (1584); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2014
Event Type  malfunction  
Event Description
It was reported that the siderail drops quickly when lowering and the access door will not unlatch.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the siderail drops quickly when lowering and the access door will not unlatch.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The customer decided not repair the unit and will replace the unit at their own discretion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CUB PEDIATRIC CRIB STRETCHER
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4261123
MDR Text Key5008829
Report Number0001831750-2014-03364
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,Followup
Report Date 11/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0190000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/07/2014
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
-
-