MAUDE Adverse Event Report: INVACARE RC 350LB FULL ELECTR BD W/ H RAIL W/FM; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 05/12/2021

Event Type  Injury  

Event Description

Per dme-gm order# (b)(4).Pt fell out of bed.Per notes, no one never came to fix/replace the bed the other day like the patient's caregiver was told now because of that the patient fell and the caregiver had to contact the fire department to help get the patient up and back in bed.Patient's caregiver very unhappy and needs the bed issue fixed immediately.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RC 350LB FULL ELECTR BD W/ H RAIL W/FM
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17532034
• MDR Text Key: 321147444
• Report Number: MW5138945
• Device Sequence Number: 1
• Product Code: LLI
• 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: 06/12/2021

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
• Patient Sequence Number: 1