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

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.

• 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 Key: 5364621
• MDR Text Key: 35945008
• Report Number: 5364621
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: MOXI 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 Date: 12/22/2015
• Device Age: NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 49