• 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, INC. COMPELLA BARIATRIC BED; BED, FLOTATION THERAPY, POWERED

  • 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, INC. COMPELLA BARIATRIC BED; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P7800A
Device Problem Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 04/01/2017
Event Type  malfunction  
Event Description
When the mattress topper is cleaned, the topper will overinflate and pop the surface, creating a ballooning effect.Manufacturer response for bariatric bed system, compella (per site reporter): mfg states ballooning is due to cleaning with blower motor running.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMPELLA BARIATRIC BED
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key6910500
MDR Text Key88073536
Report Number6910500
Device Sequence Number1
Product Code IOQ
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 09/29/2017
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 NumberP7800A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2017
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer09/29/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/03/2017
Type of Device Usage N
Patient Sequence Number1
-
-