MAUDE Adverse Event Report: INVACARE FLORIDA FULL-ELECTRIC 9153638225; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number NA:5410IVC

Device Problems Break (1069); No Device Output (1435)

Patient Problem Cough (4457)

Event Type  Injury  

Manufacturer Narrative

This medwatch is being filed in an abundance of caution due to the users medical condition being exacerbated by the lack of function of the bed.The underlying cause of the head section being unable to raise was allegedly due to a broken weld on the head section that was present from the time the bed was setup.The underlying cause of the broken weld couldn¿t be determined.The user began using this device despite being aware of the non-functional state.In the event the head section is unable to be manipulated electronically or mechanically the user can be adjusted using pillows to imitate the functions of the bed.This device was over 8 months old at the time of this incident.This device was manufactured by invacare sanford.The dealer has not responded to inquiries from the end user or invacare.Further attempts are currently ongoing to obtain further clarification and pictures related to this issue.The manual has the following statements relevant to this incident."continued use of the product with damaged parts could lead to the product malfunctioning, causing injury to the user and/or caregiver." "check all product components and carton for damage, and test components before use." "do not use product if components are damaged or if product is not working properly.Contact a qualified technician or invacare for repair.".

Event Description

The reporter stated the provider setup this bed and the head section wouldn't raise.After troubleshooting a broken weld on the head section was discovered.They stated the user came home from the hospital for an unrelated issue and began using the bed.Due to the user being unable to raise the head section there medical condition was exacerbated with coughing and they taken back to the hospital via ambulance.

Manufacturer Narrative

Additional information was received that confirmed a broken weld at the pull tube on the head section of the bed.This follow up medwatch is being filed due to additional clarification of the issue and confirmation being provided.The user is in contact with the provider to address this issue.

Event Description

The reporter stated the provider setup this bed and the head section wouldn't raise.After troubleshooting a broken weld on the head section was discovered.They stated the user came home from the hospital for an unrelated issue and began using the bed.Due to the user being unable to raise the head section there medical condition was exacerbated with coughing and they taken back to the hospital via ambulance.

• Brand Name: FULL-ELECTRIC 9153638225
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 17737774
• MDR Text Key: 323297986
• Report Number: 1031452-2023-00019
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:5410IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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): Hospitalization