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 LONDON DBA CHG HOSPITAL BEDS MDET TAXABLE; 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 LONDON DBA CHG HOSPITAL BEDS MDET TAXABLE; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 0000000001
Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
It was reported that the user account evaluated the unit and could not replicate the alleged issue of the bed not alarming when weight is removed.Therefore, the alleged product issue cannot be confirmed.
 
Event Description
It was reported that the patient fell out of bed and the bed did not alarm.The patient allegedly received a femur fracture (distal spiral nonsurgical) as a result of the fall.No details were given regarding any possible medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MDET TAXABLE
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1 R6
CA  N6E 1R6
Manufacturer (Section G)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1 R6
CA   N6E 1R6
Manufacturer Contact
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7655895
MDR Text Key112933076
Report Number3006433555-2018-00148
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 user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number0000000001
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-