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: HILL-ROM, INC. NP100 PREVENTION SURFACE MATTRESS; MATTRESS, FLOTATION THERAPY, NON-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. NP100 PREVENTION SURFACE MATTRESS; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Model Number P100A5
Device Problems Device Misassembled During Manufacturing /Shipping (2912); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2014
Event Type  Other  
Event Description
Hill-rom received a report stating, "the user facility received a mattress where the clear plastic wrapping on the mattress is labeled p100a5 but the mattress is a p100a4.A p100a4 measures 36' x 80' and a p100a5 measures 36' x 84." this report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The investigation is currently in progress to determine the root cause of the reported event.A follow-up report will be sent at the conclusion of the investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NP100 PREVENTION SURFACE MATTRESS
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
Manufacturer (Section D)
HILL-ROM, INC.
batesville IN
Manufacturer Contact
jill burnett
1069 state route 46 e
batesville, IN 47006
8129312906
MDR Report Key3698756
MDR Text Key4262752
Report Number1824206-2014-00930
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/18/2014
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 NumberP100A5
Device Catalogue NumberP100A5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/18/2014
Initial Date FDA Received03/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-