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

MAUDE Adverse Event Report: UNKNOWN MATTRESS THERAPY 42 X 84 X 6.5 9153651287; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

  • 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
 

UNKNOWN MATTRESS THERAPY 42 X 84 X 6.5 9153651287; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number UNKNOWN
Device Problem Filling Problem (1233)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It has been reported that when an unknown mattress is turned on, it will not fill the mattress.She states the unit isn't making any noise at all.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MATTRESS THERAPY 42 X 84 X 6.5 9153651287
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
UNKNOWN
OH
Manufacturer (Section G)
UNKNOWN
OH
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44036
8003336900
MDR Report Key4401353
MDR Text Key5306617
Report Number1525712-2015-00152
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/18/2014
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 Lay User/Patient
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received01/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-