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 EPIC II CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE 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 EPIC II CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 2030000000
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Head Injury (1879); Brain Injury (2219)
Event Date 02/01/2017
Event Type  Injury  
Event Description
It was reported that a four year old post-brain surgery patient fell out of bed onto their head and received a brain injury.No further information was provided regarding the details of the injury and or any medical intervention that might have been required.
 
Manufacturer Narrative
The unit was not available for inspection.Therefore, the alleged complaint cannot be confirmed.Device not available for inspection.
 
Event Description
It was reported that a four year old post-brain surgery patient fell out of bed onto their head and received a brain injury.No further information was provided regarding the details of the injury and or any medical intervention that might have been required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIC II CRITICAL CARE BED
Type of Device
BED, AC-POWERED ADJUSTABLE 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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6370233
MDR Text Key68751256
Report Number0001831750-2017-00053
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2030000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-