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: WIELAND HEALTHCARE COVE; CHAIR, WITH CASTERS
  • 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
 

WIELAND HEALTHCARE COVE; CHAIR, WITH CASTERS Back to Search Results
Model Number 53WH981U
Device Problems Unintended System Motion (1430); Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 03/21/2018
Event Type  malfunction  
Event Description
With orthopedic bariatric chair in locked position, upon patient pushing up to stand with left hand on armrest of chair, left side of chair began to slide.When weight is applied to one of the arms of the chair whether it is to stand up or sit down the chair has been known to slide away from the individual and could cause a patient to fall.The single locking mechanism does not lock all four wheels at the corners and it pivots on 2 wheels underneath the chair.Maintenance manager tried to get the chair to slide and was successful in his attempt.Two other members of the facilities maintenance team also caused it to slide as well.The manufacturer is wieland healthcare.Manufacturer response for reclining bariatric chair, recliner chair (per site reporter).Contacted (b)(6) at (b)(6).Setting up a meeting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COVE
Type of Device
CHAIR, WITH CASTERS
Manufacturer (Section D)
WIELAND HEALTHCARE
10785 rose ave
new haven IN 46774
MDR Report Key7468224
MDR Text Key106750066
Report Number7468224
Device Sequence Number1
Product Code INM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number53WH981U
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2018
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer03/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
-
-