MAUDE Adverse Event Report: UNKNOWN AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number 6629

Device Problem Break (1069)

Patient Problem Skin Tears (2516)

Event Type  No Answer Provided  

Event Description

Customer states: latch snapped off crossbar for guard rails.The model number is 6629.There is now a 6 inch gap between the mattress and the guard rail which is highly dangerous for my mother.She can get caught in this space.The cylinder in which we place the guard rail is also very sharp and i have had several gashes in my leg when i brushed against it.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4043974
• MDR Text Key: 4726612
• Report Number: 1531186-2014-03632
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/28/2014,08/05/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2014
• Distributor Facility Aware Date: 08/05/2014
• Date Report to Manufacturer: 08/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other