MAUDE Adverse Event Report: INVACARE CORP. INVACARE FULL ELECTRICAL HOME CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number INVACARE 549IVC BED

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

Patient Problem Fall (1848)

Event Date 11/18/2017

Event Type  Injury  

Event Description

(b)(6) advised of patient fall at 4:30am.(b)(6) gave a lot of push back and would not advise of the patient fall information.She stated that all she wanted was a perimeter cover and fall pads for the patient and advised me i can contact her supervisor (b)(6) if there is an issue.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE FULL ELECTRICAL HOME CARE BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 17529006
• MDR Text Key: 321139888
• Report Number: MW5135935
• 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: 11/21/2017

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: INVACARE 549IVC BED
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1