MAUDE Adverse Event Report: DRIVE DEVILBISS SIDHIL LIMITED BED 36 INV 350 LB HI-LO FULL ELECTRIC; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number BED 36 INV 350LB HI-LO FULL ELECTR RC350LOW

Patient Problem Fall (1848)

Event Date 09/07/2022

Event Type  Injury  

Event Description

According to (b)(6) she was advised that her mother climbed over the rail and fell onto the floor.(b)(6) explained that a tech was out at the residence and was advised of the fall and that he assessed the rails and advised those were the highest rails we carry.I have placed a service under (b)(4) and the family refused to have the frame or rails swapped out according to the form.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED 36 INV 350 LB HI-LO FULL ELECTRIC
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): DRIVE DEVILBISS SIDHIL LIMITED
• MDR Report Key: 17567382
• MDR Text Key: 321554389
• Report Number: MW5144700
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BED 36 INV 350LB HI-LO FULL ELECTR RC350LOW
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female