• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON BED; BED, AIR FLUIDIZED

  • 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
 

HILL-ROM BATESVILLE CLINITRON BED; BED, AIR FLUIDIZED Back to Search Results
Model Number 0800
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2015
Event Type  malfunction  
Manufacturer Narrative
The hill-rom technician found the brake casters failing.Per the hill-rom user manual, warning: patients may use the bed for support while entering or exiting; if the unit moves unexpectedly, patient injury could occur.When the unit is unattended, ensure that both brakes are locked.The brakes for the clinitron bed are located at the right, head end and the left, foot end of the unit.To apply the brakes, step on the lower end of the brake lever to lock the wheels.To release the brakes, apply inward pressure to the upper end of the brake lever.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the casters to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hill-rom received a report from the account stating the brakes were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLINITRON BED
Type of Device
BED, AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
john cummings
1069 state route 46 east
batesville, IN 47006
8129312869
MDR Report Key5235405
MDR Text Key31747631
Report Number1824206-2015-01042
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK964223
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 11/02/2015
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
Device Operator Other
Device Model Number0800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/02/2015
Initial Date FDA Received11/19/2015
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 Unknown
Patient Sequence Number1
-
-