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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROHO CORP ROHO MOXI SELECT AIR; LOW AIR LOSS MATTRESS

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ROHO CORP ROHO MOXI SELECT AIR; LOW AIR LOSS MATTRESS Back to Search Results
Model Number MOXI SELECT AIR
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hematoma (1884); Brain Injury (2219)
Event Date 12/22/2015
Event Type  Injury  
Event Description
Hospice aid was turning pt while giving a bed bath and pt accidentally rolled out of bed, landing on a cushioned fall mat on the floor.She hit her head on the floor.The mattress was installed with straps to be secured to bed frame but at the time of this incident not all straps were connected.
 
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Brand Name
ROHO MOXI SELECT AIR
Type of Device
LOW AIR LOSS MATTRESS
Manufacturer (Section D)
ROHO CORP
100 n. florida ave
belleville IL 62221
MDR Report Key5364621
MDR Text Key35945008
Report Number5364621
Device Sequence Number1
Product Code FNM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMOXI SELECT AIR
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/22/2015
Device Age NA
Event Location Nursing Home
Date Report to Manufacturer12/23/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/24/2015
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age86 YR
Patient Weight49
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