MAUDE Adverse Event Report: INVACARE FLORIDA FULL ELECTRIC BED - CANADA; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5411IVC

Device Problem Entrapment of Device (1212)

Patient Problem Loss of consciousness (2418)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

This event happened in (b)(6), however, the same device & components are sold in the us.There was no alleged malfunction of the 5411ivc bed, 6630ds half length rail or the sps1080 solace mattress by the customer.The user's husband has made adjustments to prevent his wife from rolling off the bed as she is in a frail condition.The bed & rails are still being utilized by the end user.The mattress has been replaced & the original mattress was retrieved by the dealer & placed in their rental pool.The owner's manual for the 5411ivc full electric bed recommends the 6630ds half length rail & the solace series mattress.It also states that patients with small body size may also have an increased risk of entrapment, to monitor patient frequently & read and understand the user manual prior to using the invacare bed and bed rails.The manual also states to monitor the patient frequently & to place the mattress deck in the flat position when patient is left unattended.The head & foot sections of the bed were in a raised position.

Event Description

The husband of the end user reported that he came out of the shower & found his wife with her neck stuck between the safety rail & mattress (zone 3) of her bed.The rest of her body was hanging to the floor draped in blankets.The user was unconscious & didn't appear to be breathing, there was blood in her mouth.The husband managed to move her head from between the rail and mattress and called 911.She was revived by paramedics & results from a ct scan & x-ray indicated nothing was broken, user sustained bruising.

• Brand Name: FULL ELECTRIC BED - CANADA
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE CORP; one invacare way; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035
• MDR Report Key: 13285718
• MDR Text Key: 285634391
• Report Number: 1031452-2022-00004
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5411IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female