MAUDE Adverse Event Report: INVACARE INVACARE HI-LO BED 36 350 LB FULL ELECTR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number MODEL # RC350FE, RC 350LB FULL ELECTR BD W/ H RAIL W/ FM.

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Full rails were broken, patient tried to get out of bed and fell.I emt was called and said he was "fine" and placed back in bed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE HI-LO BED 36 350 LB FULL ELECTR
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17532343
• MDR Text Key: 321061289
• Report Number: MW5139251
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MODEL # RC350FE, RC 350LB FULL ELECTR BD W/ H RAIL W/ FM.
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1