MAUDE Adverse Event Report: DRIVE MEDICAL BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number DRIVE 15005L

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 01/07/2019

Event Type  Injury  

Event Description

Caregiver (b)(6) reports the bed had moved when should have been stationary after locking causing her mother to fall to the ground.(b)(6) reports one of the wheels is broken (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 17537570
• MDR Text Key: 321061399
• Report Number: MW5144443
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: DRIVE 15005L
• Device Lot Number: 15005L
• Patient Sequence Number: 1