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 BASSINET, TRADITIONAL STYLE; PEDIATRIC OPEN HOSPITAL BED
  • 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 BASSINET, TRADITIONAL STYLE; PEDIATRIC OPEN HOSPITAL BED Back to Search Results
Catalog Number 4400324000
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the leg was broken off the bassinet.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported via repair work order that the leg was broken off the bassinet.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results which determined the base was damaged with the caster broken off.Unit was scrapped.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BASSINET, TRADITIONAL STYLE
Type of Device
PEDIATRIC OPEN HOSPITAL BED
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
anthony noora
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3778358
MDR Text Key4372869
Report Number0001831750-2014-02939
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 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4400324000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2014
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
-
-