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

Model Number 15005L, 700SC

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)

Event Date 03/13/2020

Event Type  malfunction  

Event Description

Per (b)(6) lpn, a patient fell both times in the same night.Both falls were unwitnessed.The patient did have a bruise and skin tear to the right elbow.No additional medical attention was required.1st fall, 6 pm.2nd time 8:50.Doc# (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: 17535356
• MDR Text Key: 321448337
• Report Number: MW5142253
• 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: 03/24/2020

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: 15005L, 700SC
• Patient Sequence Number: 1
• Treatment: IKY