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 2030 EPIC
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; there were worn components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the unit had reduced brake force.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIC II CRITICAL CARE BED
Common Device Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8554973
Report Number0001831750-2019-00367
Device Sequence Number467732
Product Code FNL
UDI-Device Identifier07613327348231
UDI-Public07613327348231
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K950889
Number of Events Summarized4
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2019
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
Operator of Device No Information
Device Catalogue Number2030 EPIC
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/01/2019
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-