MAUDE Adverse Event Report: ULTRA CARE ULTRA CARE; LOW AIR LOSS MATTRESS

Model Number 134922

Device Problem Filling Problem (1233)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/31/2014

Event Type  Injury  

Event Description

Patient rolled over in bed and slid out of the bed.Required first aid intervention only.It was reported that one of the cells in the mattress was not filling properly causing the mattress to "lean to one side.".

• Brand Name: ULTRA CARE
• Type of Device: LOW AIR LOSS MATTRESS
• Manufacturer (Section D): ULTRA CARE; coral springs FL 33065
• MDR Report Key: 4649563
• MDR Text Key: 15233085
• Report Number: MW5041760
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2015

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: Health Professional
• Device Model Number: 134922
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 141