MAUDE Adverse Event Report: SUNRISE MEDICAL SUNRISE; BED

Model Number U770

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 03/12/2014

Event Type  malfunction  

Event Description

Resident was holding onto the footboard when the footboard swung away from bed causing resident to lose her balance and fall.Resident has a skin tear to the left arm.Bed was switched.

• Brand Name: SUNRISE
• Type of Device: BED
• Manufacturer (Section D): SUNRISE MEDICAL; fresno CA 93727
• MDR Report Key: 3775679
• MDR Text Key: 20265226
• Report Number: MW5035778
• Device Sequence Number: 1
• Product Code: FNL
• 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: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U770
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 83 YR