MAUDE Adverse Event Report: BASIC AMERICAN METAL PRODUCTS ELECTRIC BEDS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 608-1740-0L4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Laceration(s) (1946)

Event Date 08/30/2020

Event Type  Death  

Event Description

Pt had bed come down on head; pt died.Resident on floor next to bed, the head of the bed and his bed frame came down on pt's head.Causing deep laceration.Pt had remote of bed under his body causing remote to lower bed onto head.Bed operated with remote.Resident fell on floor, bed remote behind him / under body, head of bed and side of bed came down on pt, causing laceration and pt death.Bed and remote operated properly when the accident occurred.Bed tested monthly; last testing identified no issues.

• Brand Name: ELECTRIC BEDS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BASIC AMERICAN METAL PRODUCTS ; fondulac WI 54937
• MDR Report Key: 10476196
• MDR Text Key: 205320923
• Report Number: MW5096340
• 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
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 608-1740-0L4000
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 70